Tolerance of a sterile isotonic electrolyte solution containing select recombinant growth factors in neonates recovering from necrotizing enterocolitis.

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.