Abstract
OBJECTIVE: To assess the tolerance of a sterile isotonic electrolyte solution containing select recombinant growth factors enterally administered in neonates who were NPO because of necrotizing enterocolitis (NEC).
STUDY DESIGN: A phase I trial was accomplished among 30 neonates. Patients received 5, 10, or 20 mL enterally of the study solution/kg/day divided into every 3-hour dosing, for 3 days prior to when feedings of milk were to resume. The occurrence of emesis, gastric residuals, diarrhea, bloody stools, abdominal distention, skin rashes and death were sought.
RESULTS: Gestational ages ranged from 25.2 to 41.1 weeks. A total of 16 neonates had Stage IA NEC, six Stage IB, and eight Stage IIA. The solution was well tolerated in all 30; none developed diarrhea, guaiac positive or bloody stools, or abdominal distention. Administration of the solution was not prematurely discontinued in any infant. Two neonates died secondary to late-onset sepsis remote from the study period.
CONCLUSIONS: Enteral administration of a sterile isotonic electrolyte solution containing select recombinant growth factors was well tolerated by neonates with NEC.
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Supported in part by grants HD-42326 (DAC), HD-01180 (DAC), and HL-61798 (RDC) from the National Institutes of Health.
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Lima-Rogel, V., Calhoun, D., Maheshwari, A. et al. Tolerance of a Sterile Isotonic Electrolyte Solution Containing Select Recombinant Growth Factors in Neonates Recovering From Necrotizing Enterocolitis. J Perinatol 23, 200–204 (2003). https://doi.org/10.1038/sj.jp.7210894
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DOI: https://doi.org/10.1038/sj.jp.7210894
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