1. ¹Division of Neonatology, Hospital General Dr. Ignacio Morones Prieto, San Luis Potosi City, San Luis Potosi, Mexico
2. ²Division of Neonatology, Department of Pediatrics, University of South Florida College of Medicine and All Children's Hospital, St. Petersburg, FL, 33701, USA
3. ³The National Institute of Perinatology, Mexico City, Mexico

Correspondence: Darlene A. Calhoun, Rothman Associate Professor, USF/ACH Children's Research Institute, 140 Seventh Ave. South CRI Rm 2006, St. Petersburg, FL 33701 USA

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.