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Published on: February 15, 2018
Tolerance of a sterile isotonic electrolyte solution containing select recombinant growth factors in neonates
Victoria Lima-Rogel1, Darlene A Calhoun, Akhil Maheshwari
1Division of Neonatology, Hospital General Dr. Ignacio Morones Prieto, San Luis Potosi City, San Luis Potosi, Mexico.
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.
