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Alejandro Mondolfi - One of the best experts on this subject based on the ideXlab platform.
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Oral Rehydration Solutions: A Randomized Clinical Trial Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based
2013Co-Authors: Alejandro Mondolfi, Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. AdamsAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 6 10 mEq/L, and for the packet CBORS group, 54 6 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use. Pediatrics 1997;100(5). URL: http://www. pediatrics.org/cgi/content/full/100/5/e3; diarrhea, dehydration, oral rehydration, cereal. ABBREVIATIONS. ORT, oral rehydration therapy; ORS, oral rehydration solutions; CBORS, cereal-based oral rehydration solutions; CI, confidence interval. Acute infectious diarrhea is a common illness in young children worldwide and in the United States, where children average between 1.3 and 2.3 episodes per child per year for the first 5 years of life.1 Each year, approximately 1 of 5 children ,5 years of age sees a physician for diarrhea, and 1.4% are hospitalized, resulting in .200 000 hospital admissions, or 10.6% of all admissions in this age group.1 It has been estimated that the annual national cost of hospitalization for rotavirus-associated gastroenteritis was $352 million in 1988.2 Some 300 children ,5 years of age die in the United States each year because of diarrhea, a rate that has not declined since 1985. These deaths occur primarily in infants and disproportionately among those who are African-American, premature, and living in Southern states and in metropolitan areas.3 Oral rehydration therapy (ORT) is safe, effective, less invasive, and less expensive than intravenous rehydration for the treatment of diarrheal dehydration, and its use in the home early in the course of illness can prevent the development of dehydration.4–8 ORT has been promoted in practice guidelines published by the American Academy of Pediatrics (AAP)9,10 and the Centers for Disease Control and Prevention.11 However, there are economic barriers to the use of ORT for low-income families,12 who may have to pay .$6 per liter in their neighborhood pharmacy for commercial oral rehydration solutions (ORS). Coverage of commercial ORS varies among the state Medicaid programs,13 and one fourth of children in low-income families in the United States have no health insurance coverage at all.14 A possible approach to this problem is the promoFrom the *Division of General Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; ‡Division of Emergency Medicine, Children’s Hospital, Harvard Medical School, Boston, Massachusetts; and §Department of Maternal and Child Health, Harvard School of Public Health, Boston, Massachusetts. This work was presented, in part, at the Ambulatory Pediatric Association Annual Meeting, Washington, DC, May 9, 1996. Dr Sampson is currently at the Perinatal Epidemiology Unit, Department of Epidemiology and Public Health, Yale University School of Medicine, New
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Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based Oral Rehydration Solutions: A Randomized Clinical Trial
Pediatrics, 1997Co-Authors: Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. Adams, Alejandro MondolfiAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 ± 10 mEq/L, and for the packet CBORS group, 54 ± 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.
Alan Meyers - One of the best experts on this subject based on the ideXlab platform.
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Oral Rehydration Solutions: A Randomized Clinical Trial Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based
2013Co-Authors: Alejandro Mondolfi, Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. AdamsAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 6 10 mEq/L, and for the packet CBORS group, 54 6 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use. Pediatrics 1997;100(5). URL: http://www. pediatrics.org/cgi/content/full/100/5/e3; diarrhea, dehydration, oral rehydration, cereal. ABBREVIATIONS. ORT, oral rehydration therapy; ORS, oral rehydration solutions; CBORS, cereal-based oral rehydration solutions; CI, confidence interval. Acute infectious diarrhea is a common illness in young children worldwide and in the United States, where children average between 1.3 and 2.3 episodes per child per year for the first 5 years of life.1 Each year, approximately 1 of 5 children ,5 years of age sees a physician for diarrhea, and 1.4% are hospitalized, resulting in .200 000 hospital admissions, or 10.6% of all admissions in this age group.1 It has been estimated that the annual national cost of hospitalization for rotavirus-associated gastroenteritis was $352 million in 1988.2 Some 300 children ,5 years of age die in the United States each year because of diarrhea, a rate that has not declined since 1985. These deaths occur primarily in infants and disproportionately among those who are African-American, premature, and living in Southern states and in metropolitan areas.3 Oral rehydration therapy (ORT) is safe, effective, less invasive, and less expensive than intravenous rehydration for the treatment of diarrheal dehydration, and its use in the home early in the course of illness can prevent the development of dehydration.4–8 ORT has been promoted in practice guidelines published by the American Academy of Pediatrics (AAP)9,10 and the Centers for Disease Control and Prevention.11 However, there are economic barriers to the use of ORT for low-income families,12 who may have to pay .$6 per liter in their neighborhood pharmacy for commercial oral rehydration solutions (ORS). Coverage of commercial ORS varies among the state Medicaid programs,13 and one fourth of children in low-income families in the United States have no health insurance coverage at all.14 A possible approach to this problem is the promoFrom the *Division of General Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; ‡Division of Emergency Medicine, Children’s Hospital, Harvard Medical School, Boston, Massachusetts; and §Department of Maternal and Child Health, Harvard School of Public Health, Boston, Massachusetts. This work was presented, in part, at the Ambulatory Pediatric Association Annual Meeting, Washington, DC, May 9, 1996. Dr Sampson is currently at the Perinatal Epidemiology Unit, Department of Epidemiology and Public Health, Yale University School of Medicine, New
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Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based Oral Rehydration Solutions: A Randomized Clinical Trial
Pediatrics, 1997Co-Authors: Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. Adams, Alejandro MondolfiAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 ± 10 mEq/L, and for the packet CBORS group, 54 ± 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.
William G. Adams - One of the best experts on this subject based on the ideXlab platform.
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Oral Rehydration Solutions: A Randomized Clinical Trial Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based
2013Co-Authors: Alejandro Mondolfi, Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. AdamsAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 6 10 mEq/L, and for the packet CBORS group, 54 6 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use. Pediatrics 1997;100(5). URL: http://www. pediatrics.org/cgi/content/full/100/5/e3; diarrhea, dehydration, oral rehydration, cereal. ABBREVIATIONS. ORT, oral rehydration therapy; ORS, oral rehydration solutions; CBORS, cereal-based oral rehydration solutions; CI, confidence interval. Acute infectious diarrhea is a common illness in young children worldwide and in the United States, where children average between 1.3 and 2.3 episodes per child per year for the first 5 years of life.1 Each year, approximately 1 of 5 children ,5 years of age sees a physician for diarrhea, and 1.4% are hospitalized, resulting in .200 000 hospital admissions, or 10.6% of all admissions in this age group.1 It has been estimated that the annual national cost of hospitalization for rotavirus-associated gastroenteritis was $352 million in 1988.2 Some 300 children ,5 years of age die in the United States each year because of diarrhea, a rate that has not declined since 1985. These deaths occur primarily in infants and disproportionately among those who are African-American, premature, and living in Southern states and in metropolitan areas.3 Oral rehydration therapy (ORT) is safe, effective, less invasive, and less expensive than intravenous rehydration for the treatment of diarrheal dehydration, and its use in the home early in the course of illness can prevent the development of dehydration.4–8 ORT has been promoted in practice guidelines published by the American Academy of Pediatrics (AAP)9,10 and the Centers for Disease Control and Prevention.11 However, there are economic barriers to the use of ORT for low-income families,12 who may have to pay .$6 per liter in their neighborhood pharmacy for commercial oral rehydration solutions (ORS). Coverage of commercial ORS varies among the state Medicaid programs,13 and one fourth of children in low-income families in the United States have no health insurance coverage at all.14 A possible approach to this problem is the promoFrom the *Division of General Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; ‡Division of Emergency Medicine, Children’s Hospital, Harvard Medical School, Boston, Massachusetts; and §Department of Maternal and Child Health, Harvard School of Public Health, Boston, Massachusetts. This work was presented, in part, at the Ambulatory Pediatric Association Annual Meeting, Washington, DC, May 9, 1996. Dr Sampson is currently at the Perinatal Epidemiology Unit, Department of Epidemiology and Public Health, Yale University School of Medicine, New
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Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based Oral Rehydration Solutions: A Randomized Clinical Trial
Pediatrics, 1997Co-Authors: Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. Adams, Alejandro MondolfiAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 ± 10 mEq/L, and for the packet CBORS group, 54 ± 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.
Mitchell B. Cohen - One of the best experts on this subject based on the ideXlab platform.
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Use of a single solution for oral rehydration and maintenance therapy of infants with diarrhea and mild to moderate dehydration.
Pediatrics, 1995Co-Authors: Mitchell B. Cohen, Adam Mezoff, D. W. Laney, Jorge A. Bezerra, B M Beane, D Drazner, R Baker, J R MoranAbstract:Objective. To compare the efficacy of two commonly used solutions in the rehydration of infants with mild to moderate dehydration caused by acute diarrhea in the United States. Design and setting. Double-blind, parallel-group, randomized study performed at Children9s Hospital Medical Center. Patients. Sixty infant boys (≤2 years old), with mild (≤5%) or moderate (6 to 9%) dehydration caused by acute diarrhea of less than 1 week9s duration were included in the study. Interventions. Infants were randomly assigned to receive treatment with either a glucose-based oral rehydration solution (ORS) (Pedialyte, Ross Laboratories, Columbus, OH) or a rice syrup solids-based ORS (Infalyte, Mead Johnson Nutritional Group, Evansville, IN). After rehydration was achieved, patients entered a maintenance phase during which, in addition to a maintenance ORS, breast milk or a soy-based formula was offered infants older than 1 year were also given a lactose-free diet. Outcome measures. Rehydration was judged clinically. Infants remained on a metabolic bed during the study in to separate and quantitate urine and stool output. Therefore, in addition to clinical outcome, we compared intake, output and apparent absorption and retention of fluid, sodium, and potassium between groups. Results. All patients were successfully rehydrated using an ORS without the use of intravenous fluids. No differences were detected between treatment groups in time to rehydration, percentage of weight gain after rehydration, consumption of ORS to achieve rehydration, or stool output. However, the apparent sodium absorption (net intake less fecal output) was greater in the Infalyte group than the Pedialyte group during the first 24 hours. Conclusion. The two maintenance oral electrolyte solutions (Pedialyte and Infalyte) most commonly used in the United States are effective as rehydration solutions for infants with mild to moderate dehydration. We speculate that a strategy for oral rehydration therapy in the United States, based on the use of a single solution during the rehydration and maintenance phase, might gain additional acceptance by practicing pediatricians and family physicians.
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Medicaid coverage of oral rehydration solutions.
The New England journal of medicine, 1993Co-Authors: Mitchell B. Cohen, Judy HardinAbstract:To the Editor: Oral rehydration solutions have been recommended for the treatment and prevention of dehydration due to diarrhea in the United States1,2 and worldwide3. Although several of these solutions are commercially available in the United States, they are not uniformly available to indigent children4. During the period March 5 through 18, 1993, we contacted by telephone the Medicaid agency in each state and in the District of Columbia. In this survey, we sought to determine whether Pedialyte (National Drug Code 0074-6470-32), Ricelyte (0087-1403-42), and Rehydralyte (0074-0162-01), the three most commonly used oral rehydration solutions in the . . .
Sujata Dixit - One of the best experts on this subject based on the ideXlab platform.
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Oral Rehydration Solutions: A Randomized Clinical Trial Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based
2013Co-Authors: Alejandro Mondolfi, Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. AdamsAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 6 10 mEq/L, and for the packet CBORS group, 54 6 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use. Pediatrics 1997;100(5). URL: http://www. pediatrics.org/cgi/content/full/100/5/e3; diarrhea, dehydration, oral rehydration, cereal. ABBREVIATIONS. ORT, oral rehydration therapy; ORS, oral rehydration solutions; CBORS, cereal-based oral rehydration solutions; CI, confidence interval. Acute infectious diarrhea is a common illness in young children worldwide and in the United States, where children average between 1.3 and 2.3 episodes per child per year for the first 5 years of life.1 Each year, approximately 1 of 5 children ,5 years of age sees a physician for diarrhea, and 1.4% are hospitalized, resulting in .200 000 hospital admissions, or 10.6% of all admissions in this age group.1 It has been estimated that the annual national cost of hospitalization for rotavirus-associated gastroenteritis was $352 million in 1988.2 Some 300 children ,5 years of age die in the United States each year because of diarrhea, a rate that has not declined since 1985. These deaths occur primarily in infants and disproportionately among those who are African-American, premature, and living in Southern states and in metropolitan areas.3 Oral rehydration therapy (ORT) is safe, effective, less invasive, and less expensive than intravenous rehydration for the treatment of diarrheal dehydration, and its use in the home early in the course of illness can prevent the development of dehydration.4–8 ORT has been promoted in practice guidelines published by the American Academy of Pediatrics (AAP)9,10 and the Centers for Disease Control and Prevention.11 However, there are economic barriers to the use of ORT for low-income families,12 who may have to pay .$6 per liter in their neighborhood pharmacy for commercial oral rehydration solutions (ORS). Coverage of commercial ORS varies among the state Medicaid programs,13 and one fourth of children in low-income families in the United States have no health insurance coverage at all.14 A possible approach to this problem is the promoFrom the *Division of General Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; ‡Division of Emergency Medicine, Children’s Hospital, Harvard Medical School, Boston, Massachusetts; and §Department of Maternal and Child Health, Harvard School of Public Health, Boston, Massachusetts. This work was presented, in part, at the Ambulatory Pediatric Association Annual Meeting, Washington, DC, May 9, 1996. Dr Sampson is currently at the Perinatal Epidemiology Unit, Department of Epidemiology and Public Health, Yale University School of Medicine, New
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Safety and Effectiveness of Homemade and Reconstituted Packet Cereal-based Oral Rehydration Solutions: A Randomized Clinical Trial
Pediatrics, 1997Co-Authors: Alan Meyers, Amy Sampson, Richard Saladino, Sujata Dixit, William G. Adams, Alejandro MondolfiAbstract:Objectives. Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight. Results. A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 ± 10 mEq/L, and for the packet CBORS group, 54 ± 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain. Conclusions. CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.