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Peter A. Dargaville - One of the best experts on this subject based on the ideXlab platform.
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Impact of Minimally Invasive Surfactant Therapy in Preterm Infants at 29-32 Weeks Gestation.
Neonatology, 2017Co-Authors: Peter A. Dargaville, Sanoj K M Ali, Hamish D Jackson, C.d. Williams, Antonio G De PaoliAbstract:Background: Most preterm infants born at 29-32 weeks gestation now avoid intubation in early life, and thus lack the usual conduit through which exogenous Surfactant is given if needed. Objective: The aim of this work was to examine whether a technique of minimally invasive Surfactant Therapy used selectively at 29-32 weeks gestation would improve outcomes. Methods: We studied the impact of selective administration of Surfactant (poractant alfa 100-200 mg/kg) by thin catheter in infants with respiratory distress syndrome on continuous positive airway pressure (CPAP). The threshold for consideration of treatment was CPAP ≥7 cm H 2 O and FiO 2 ≥0.35 prior to 24 h of life. In-hospital outcomes were compared before and after introducing minimally invasive Surfactant Therapy (epochs 1 and 2, respectively). Results: During epoch 2, of 266 infants commencing CPAP, 51 (19%) reached the treatment threshold. Thirty-seven infants received Surfactant via thin catheter, and CPAP failure was avoided in 34 of these (92%). For the overall cohort of infants at 29-32 weeks gestation, after the introduction of minimally invasive Surfactant Therapy, there were reductions in CPAP failure (epoch 1: 14%, epoch 2: 7.2%) and average days of intubation, with equivalent Surfactant use and days of respiratory support (intubation + CPAP). Pneumothorax was substantially reduced (from 8.0 to 2.4%). These findings were mirrored within the subgroups reaching the severity threshold in each epoch. The incidence of bronchopulmonary dysplasia was low in both epochs. Conclusions: Selective use of minimally invasive Surfactant Therapy at 29-32 weeks gestation permits a primary CPAP strategy to be pursued with a high rate of success, and a low risk of pneumothorax.
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The OPTIMIST-A trial: evaluation of minimally-invasive Surfactant Therapy in preterm infants 25–28 weeks gestation
BMC pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. Soll, Peter G DavisAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
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the optimist a trial evaluation of minimally invasive Surfactant Therapy in preterm infants 25 28 weeks gestation
BMC Pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Peter G Davis, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. SollAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
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Minimally Invasive Surfactant Therapy: An Update
NeoReviews, 2014Co-Authors: Marta Aguar, Máximo Vento, Peter A. DargavilleAbstract:Preterm infants who have respiratory distress syndrome have for many years been managed with a combination of early intubation and exogenous Surfactant Therapy. It is now recognized that applying continuous positive airway pressure (CPAP) in an extremely preterm infant is a reasonable alternative to early intubation after birth. Meta-analysis of large controlled trials comparing these two approaches suggests a benefit of CPAP, with a small reduction in the risk of the composite outcome of death or bronchopulmonary dysplasia. In the past decade, there has been an upsurge in the use of CPAP as primary Therapy for preterm infants, bringing with it the dilemma of whether and how to give exogenous Surfactant. In an effort to circumvent this problem, techniques of minimally invasive Surfactant Therapy have recently been investigated, aiming to administer Surfactant to spontaneously breathing infants, allowing them to remain on CPAP in the critical first days after birth and, hopefully, beyond. These techniques have included administration of exogenous Surfactant by brief tracheal catheterization, aerosolization, and laryngeal mask. Of these, the methods involving brief tracheal catheterization have been most extensively studied, with Surfactant administered by using both a flexible feeding tube and a semi-rigid vascular catheter. In recent clinical trials (AMV [Avoidance of Mechanical Ventilation by Surfactant Administration] trial, Take Care study, and NINSAPP [Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure in Premature Infants
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Innovation in Surfactant Therapy I: Surfactant lavage and Surfactant administration by fluid bolus using minimally invasive techniques.
Neonatology, 2012Co-Authors: Peter A. DargavilleAbstract:Innovation in the field of exogenous Surfactant Therapy continues more than two decades after the drug became commercially available. One such innovation, lung lavage using dilute Surfactant, has been investigated in both laboratory and clinical settings as a treatment for meconium aspiration syndrome (MAS). Studies in animal models of MAS have affirmed that dilute Surfactant lavage can remove meconium from the lung, with resultant improvement in lung function. In human infants both non-randomised studies and two randomised controlled trials have demonstrated a potential benefit of dilute Surfactant lavage over standard care. The largest clinical trial, performed by our research group in infants with severe MAS, found that lung lavage using two 15-ml/kg aliquots of dilute Surfactant did not reduce the duration of respiratory support, but did appear to reduce the composite outcome of death or need for extracorporeal membrane oxygenation. A further trial of lavage Therapy is planned to more precisely define the effect on survival. Innovative approaches to Surfactant Therapy have also extended to the preterm infant, for whom the more widespread use of continuous positive airway pressure (CPAP) has meant delaying or avoiding administration of Surfactant. In an effort to circumvent this problem, less invasive techniques of bolus Surfactant Therapy have been trialled, including instillation directly into the pharynx, via laryngeal mask and via brief tracheal catheterisation. In a recent clinical trial, instillation of Surfactant into the trachea using a flexible feeding tube was found to reduce the need for subsequent intubation. We have developed an alternative method of brief tracheal catheterisation in which Surfactant is delivered via a semi-rigid vascular catheter inserted through the vocal cords under direct vision. In studies to date, this technique has been relatively easy to perform, and resulted in rapid improvement in lung function and reduced need for subsequent ventilation and duration of oxygen Therapy. We are now commencing large-scale clinical trials of this method in preterm infants on CPAP.
Peter G Davis - One of the best experts on this subject based on the ideXlab platform.
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Lung ultrasound immediately after birth predicts the need for Surfactant Therapy in very- and extremely preterm infants, the DOLFIN Jr Study
2020Co-Authors: Shiraz Badurdeen, C. Omar F Kamlin, Sheryle R Rogerson, Stefan C Kane, Graeme R Polglase, Stuart B Hooper, Peter G Davis, Douglas A BlankAbstract:Abstract BackgroundEarly identification of infants requiring Surfactant Therapy improves outcomes. We evaluated the accuracy of delivery room lung ultrasound (LUS) to predict Surfactant Therapy in very- and extremely preterm infants.MethodsInfants born at <320/7 weeks were prospectively enrolled with parental consent at 2 centres. LUS videos of both sides of the chest were obtained 5-10 minutes, 11-20 minutes, and 1-3 hours after birth. Clinicians were masked to the results of the LUS assessment and Surfactant Therapy was provided according to local guidelines. LUS videos were graded blinded to clinical data. Presence of unilateral type 1 (‘whiteout’) LUS or worse was considered test positive. Receiver Operating Characteristic (ROC) analysis compared the accuracy of LUS and an FiO2 threshold of 0.3 to predict subsequent Surfactant Therapy.ResultsFifty-two infants with a median age of 276/7 weeks (IQR 260/7 to 286/7) were studied. Thirty infants (58%) received Surfactant. Area under the ROC curve (AUC) for LUS at 5-10 minutes, 11-20 minutes and 1-3 hours was 0.78 (95% CI, 0.66–0.90), 0.76 (95% CI, 0.65-0.88) and 0.86 (95% CI, 0.75-0.97) respectively, outperforming FiO2 at the 5-10 minute timepoint (AUC 0.45, 95% CI 0.29-0.62, p=0.001). At 11-20 minutes, LUS had a specificity of 95% (95% CI 77-100%) and sensitivity of 59% (95% CI, 39-77%) to predict Surfactant Therapy. All infants born at 23-276/7 weeks with LUS test positive received Surfactant. Twenty-six infants (50%) had worsening of LUS grades on serial assessment.ConclusionsLUS in the delivery room is feasible and accurately predicts Surfactant Therapy in infants <320/7 weeks. Study registration: ACTRN12617001256369
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The OPTIMIST-A trial: evaluation of minimally-invasive Surfactant Therapy in preterm infants 25–28 weeks gestation
BMC pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. Soll, Peter G DavisAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
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the optimist a trial evaluation of minimally invasive Surfactant Therapy in preterm infants 25 28 weeks gestation
BMC Pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Peter G Davis, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. SollAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
Atul Malhotra - One of the best experts on this subject based on the ideXlab platform.
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Fetal growth restriction is associated with an altered cardiopulmonary and cerebral hemodynamic response to Surfactant Therapy in preterm lambs
Pediatric Research, 2019Co-Authors: Atul Malhotra, Stuart B Hooper, Arvind Sehgal, Suzanne L. Miller, Graham Jenkin, Beth J. Allison, Foula Sozo, Valerie Zahra, Graeme R PolglaseAbstract:Background Efficacy of Surfactant Therapy in fetal growth restricted (FGR) preterm neonates is unknown. Methods Twin-bearing ewes underwent surgery at 105 days gestation to induce FGR in one twin by single umbilical artery ligation. At 123–127 days, catheters and flow probes were implanted in pulmonary and carotid arteries to measure flow and pressure. Lambs were delivered, intubated and mechanically ventilated. At 10 min, Surfactant (100 mg kg^−1) was administered. Ventilation, oxygenation, and hemodynamic responses were recorded for 1 h before euthanasia at 120 min. Lung tissue and bronchoalveolar lavage fluid was collected for analysis of Surfactant protein mRNA and phosphatidylcholines (PCs). Results FGR preterm lambs were 26% lighter than appropriate for gestational age (AGA) lambs and had baseline differences in lung mechanics and pulmonary blood flows. Surfactant Therapy reduced ventilator and oxygen requirements and improved lung mechanics in both groups, although a more rapid improvement in compliance and tidal volume was observed in AGA lambs. Surfactant administration was associated with decreased mean pulmonary and carotid blood flow in FGR but not AGA lambs. No major differences in Surfactant protein mRNA or PC levels were noted. Conclusions Surfactant Therapy was associated with an altered pulmonary and cerebral hemodynamic response in preterm FGR lambs.
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Fetal growth restriction is associated with an altered cardiopulmonary and cerebral hemodynamic response to Surfactant Therapy in preterm lambs
Pediatric research, 2019Co-Authors: Atul Malhotra, Stuart B Hooper, Arvind Sehgal, Suzanne L. Miller, Graham Jenkin, Beth J. Allison, Foula Sozo, Valerie A. Zahra, Graeme R PolglaseAbstract:Efficacy of Surfactant Therapy in fetal growth restricted (FGR) preterm neonates is unknown. Twin-bearing ewes underwent surgery at 105 days gestation to induce FGR in one twin by single umbilical artery ligation. At 123–127 days, catheters and flow probes were implanted in pulmonary and carotid arteries to measure flow and pressure. Lambs were delivered, intubated and mechanically ventilated. At 10 min, Surfactant (100 mg kg−1) was administered. Ventilation, oxygenation, and hemodynamic responses were recorded for 1 h before euthanasia at 120 min. Lung tissue and bronchoalveolar lavage fluid was collected for analysis of Surfactant protein mRNA and phosphatidylcholines (PCs). FGR preterm lambs were 26% lighter than appropriate for gestational age (AGA) lambs and had baseline differences in lung mechanics and pulmonary blood flows. Surfactant Therapy reduced ventilator and oxygen requirements and improved lung mechanics in both groups, although a more rapid improvement in compliance and tidal volume was observed in AGA lambs. Surfactant administration was associated with decreased mean pulmonary and carotid blood flow in FGR but not AGA lambs. No major differences in Surfactant protein mRNA or PC levels were noted. Surfactant Therapy was associated with an impaired pulmonary and cerebral hemodynamic response in preterm FGR lambs.
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fetal growth restriction is associated with an altered cardiopulmonary and cerebral hemodynamic response to Surfactant Therapy in preterm lambs
Pediatric Research, 2019Co-Authors: Stuart B Hooper, Atul Malhotra, Suzanne L. Miller, Graham Jenkin, Beth J. AllisonAbstract:Efficacy of Surfactant Therapy in fetal growth restricted (FGR) preterm neonates is unknown. Twin-bearing ewes underwent surgery at 105 days gestation to induce FGR in one twin by single umbilical artery ligation. At 123–127 days, catheters and flow probes were implanted in pulmonary and carotid arteries to measure flow and pressure. Lambs were delivered, intubated and mechanically ventilated. At 10 min, Surfactant (100 mg kg−1) was administered. Ventilation, oxygenation, and hemodynamic responses were recorded for 1 h before euthanasia at 120 min. Lung tissue and bronchoalveolar lavage fluid was collected for analysis of Surfactant protein mRNA and phosphatidylcholines (PCs). FGR preterm lambs were 26% lighter than appropriate for gestational age (AGA) lambs and had baseline differences in lung mechanics and pulmonary blood flows. Surfactant Therapy reduced ventilator and oxygen requirements and improved lung mechanics in both groups, although a more rapid improvement in compliance and tidal volume was observed in AGA lambs. Surfactant administration was associated with decreased mean pulmonary and carotid blood flow in FGR but not AGA lambs. No major differences in Surfactant protein mRNA or PC levels were noted. Surfactant Therapy was associated with an altered pulmonary and cerebral hemodynamic response in preterm FGR lambs.
Antonio G De Paoli - One of the best experts on this subject based on the ideXlab platform.
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Impact of Minimally Invasive Surfactant Therapy in Preterm Infants at 29-32 Weeks Gestation.
Neonatology, 2017Co-Authors: Peter A. Dargaville, Sanoj K M Ali, Hamish D Jackson, C.d. Williams, Antonio G De PaoliAbstract:Background: Most preterm infants born at 29-32 weeks gestation now avoid intubation in early life, and thus lack the usual conduit through which exogenous Surfactant is given if needed. Objective: The aim of this work was to examine whether a technique of minimally invasive Surfactant Therapy used selectively at 29-32 weeks gestation would improve outcomes. Methods: We studied the impact of selective administration of Surfactant (poractant alfa 100-200 mg/kg) by thin catheter in infants with respiratory distress syndrome on continuous positive airway pressure (CPAP). The threshold for consideration of treatment was CPAP ≥7 cm H 2 O and FiO 2 ≥0.35 prior to 24 h of life. In-hospital outcomes were compared before and after introducing minimally invasive Surfactant Therapy (epochs 1 and 2, respectively). Results: During epoch 2, of 266 infants commencing CPAP, 51 (19%) reached the treatment threshold. Thirty-seven infants received Surfactant via thin catheter, and CPAP failure was avoided in 34 of these (92%). For the overall cohort of infants at 29-32 weeks gestation, after the introduction of minimally invasive Surfactant Therapy, there were reductions in CPAP failure (epoch 1: 14%, epoch 2: 7.2%) and average days of intubation, with equivalent Surfactant use and days of respiratory support (intubation + CPAP). Pneumothorax was substantially reduced (from 8.0 to 2.4%). These findings were mirrored within the subgroups reaching the severity threshold in each epoch. The incidence of bronchopulmonary dysplasia was low in both epochs. Conclusions: Selective use of minimally invasive Surfactant Therapy at 29-32 weeks gestation permits a primary CPAP strategy to be pursued with a high rate of success, and a low risk of pneumothorax.
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The OPTIMIST-A trial: evaluation of minimally-invasive Surfactant Therapy in preterm infants 25–28 weeks gestation
BMC pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. Soll, Peter G DavisAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
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the optimist a trial evaluation of minimally invasive Surfactant Therapy in preterm infants 25 28 weeks gestation
BMC Pediatrics, 2014Co-Authors: Peter A. Dargaville, Antonio G De Paoli, Peter G Davis, Camille Omar Farouk Kamlin, John B. Carlin, Francesca Orsini, Roger F. SollAbstract:It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory Therapy may fail to adequately support those infants with significant Surfactant deficiency, with the result that intubation and delayed Surfactant Therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive Surfactant Therapy have been developed, in which exogenous Surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of Surfactant delivery using a semi-rigid Surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous Surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Minimally-invasive Surfactant Therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .
Arvind Sehgal - One of the best experts on this subject based on the ideXlab platform.
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cardiovascular response and sequelae after minimally invasive Surfactant Therapy in growth restricted preterm infants
Journal of Perinatology, 2020Co-Authors: Arvind Sehgal, Risha Bhatia, Calum T RobertsAbstract:To study cardiovascular response to minimally invasive Surfactant Therapy in preterm infants with and without foetal growth restriction (FGR). Poractant alfa was administered and echocardiograms were performed before and 30 min after. FGR infants were compared with those appropriate for gestational age (AGA). Ten FGR infants were compared with 20 AGA infants (gestation [weeks], 28.9 ± 2 vs. 28.6 ± 1, p = 0.55 and birthweight [g], 813 ± 157 vs. 1141 ± 257, p = 0.01, respectively). The change in echocardiographic parameters was more prominent in AGA infants ([global contractility] fractional area change [FAC, %], FGR, 24.7 ± 2.2 to 27.9 ± 0.4, p = 0.08 vs. AGA, 26.6 ± 3 to 30.5 ± 1, p < 0.01, and [longitudinal contractility] tricuspid annular plane systolic excursion [mm], FGR, 3.9 ± 0.3 to 4.6 ± 0.5, p = 0.003 vs. AGA, 4.6 ± 0.3 to 5.5 ± 0.4, p = 0.0001). Significant difference was noted for change in FAC (%), FGR 2.1 ± 1.7 vs. AGA 4.1 ± 1.2, p = 0.02. Differential cardiovascular response to minimally invasive Surfactant Therapy amongst FGR infants may reflect an in-utero maladaptive state.
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Cardiovascular response and sequelae after minimally invasive Surfactant Therapy in growth-restricted preterm infants.
Journal of perinatology : official journal of the California Perinatal Association, 2020Co-Authors: Arvind Sehgal, Risha Bhatia, Calum T RobertsAbstract:To study cardiovascular response to minimally invasive Surfactant Therapy in preterm infants with and without foetal growth restriction (FGR). Poractant alfa was administered and echocardiograms were performed before and 30 min after. FGR infants were compared with those appropriate for gestational age (AGA). Ten FGR infants were compared with 20 AGA infants (gestation [weeks], 28.9 ± 2 vs. 28.6 ± 1, p = 0.55 and birthweight [g], 813 ± 157 vs. 1141 ± 257, p = 0.01, respectively). The change in echocardiographic parameters was more prominent in AGA infants ([global contractility] fractional area change [FAC, %], FGR, 24.7 ± 2.2 to 27.9 ± 0.4, p = 0.08 vs. AGA, 26.6 ± 3 to 30.5 ± 1, p
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Fetal growth restriction is associated with an altered cardiopulmonary and cerebral hemodynamic response to Surfactant Therapy in preterm lambs
Pediatric Research, 2019Co-Authors: Atul Malhotra, Stuart B Hooper, Arvind Sehgal, Suzanne L. Miller, Graham Jenkin, Beth J. Allison, Foula Sozo, Valerie Zahra, Graeme R PolglaseAbstract:Background Efficacy of Surfactant Therapy in fetal growth restricted (FGR) preterm neonates is unknown. Methods Twin-bearing ewes underwent surgery at 105 days gestation to induce FGR in one twin by single umbilical artery ligation. At 123–127 days, catheters and flow probes were implanted in pulmonary and carotid arteries to measure flow and pressure. Lambs were delivered, intubated and mechanically ventilated. At 10 min, Surfactant (100 mg kg^−1) was administered. Ventilation, oxygenation, and hemodynamic responses were recorded for 1 h before euthanasia at 120 min. Lung tissue and bronchoalveolar lavage fluid was collected for analysis of Surfactant protein mRNA and phosphatidylcholines (PCs). Results FGR preterm lambs were 26% lighter than appropriate for gestational age (AGA) lambs and had baseline differences in lung mechanics and pulmonary blood flows. Surfactant Therapy reduced ventilator and oxygen requirements and improved lung mechanics in both groups, although a more rapid improvement in compliance and tidal volume was observed in AGA lambs. Surfactant administration was associated with decreased mean pulmonary and carotid blood flow in FGR but not AGA lambs. No major differences in Surfactant protein mRNA or PC levels were noted. Conclusions Surfactant Therapy was associated with an altered pulmonary and cerebral hemodynamic response in preterm FGR lambs.
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Fetal growth restriction is associated with an altered cardiopulmonary and cerebral hemodynamic response to Surfactant Therapy in preterm lambs
Pediatric research, 2019Co-Authors: Atul Malhotra, Stuart B Hooper, Arvind Sehgal, Suzanne L. Miller, Graham Jenkin, Beth J. Allison, Foula Sozo, Valerie A. Zahra, Graeme R PolglaseAbstract:Efficacy of Surfactant Therapy in fetal growth restricted (FGR) preterm neonates is unknown. Twin-bearing ewes underwent surgery at 105 days gestation to induce FGR in one twin by single umbilical artery ligation. At 123–127 days, catheters and flow probes were implanted in pulmonary and carotid arteries to measure flow and pressure. Lambs were delivered, intubated and mechanically ventilated. At 10 min, Surfactant (100 mg kg−1) was administered. Ventilation, oxygenation, and hemodynamic responses were recorded for 1 h before euthanasia at 120 min. Lung tissue and bronchoalveolar lavage fluid was collected for analysis of Surfactant protein mRNA and phosphatidylcholines (PCs). FGR preterm lambs were 26% lighter than appropriate for gestational age (AGA) lambs and had baseline differences in lung mechanics and pulmonary blood flows. Surfactant Therapy reduced ventilator and oxygen requirements and improved lung mechanics in both groups, although a more rapid improvement in compliance and tidal volume was observed in AGA lambs. Surfactant administration was associated with decreased mean pulmonary and carotid blood flow in FGR but not AGA lambs. No major differences in Surfactant protein mRNA or PC levels were noted. Surfactant Therapy was associated with an impaired pulmonary and cerebral hemodynamic response in preterm FGR lambs.