Enteral administration of a simulated amniotic fluid in preventing feeding intolerance in very low birthweight neonates: A randomized controlled trial

Feeding intolerance (FI) is a common finding in preterm neonates. Enteral administration of different forms of amniotic fluid (AF) has been tried for treating FI in high-risk neonates. Simulated amniotic fluid (SAF) is a solution with a similar electrolyte composition to human AF. The aim of this study was to examine whether enteral administration of SAF would improve feeding tolerance in very low birthweight (VLBW) neonates. Forty VLBW neonates were randomized to either SAF or placebo (total daily dose 20 mL/kg/d–1 divided every 3 h) to their milk for a maximum of 7 d. Neonates with major congenital anomalies, those in whom early feeding was contraindicated, and those treated with parental erythropoietin and/or human granulocyte stimulating factor were excluded. The primary outcome was the total amount of enteral feeds reached by day 7. Secondary outcomes were incidence of FI and necrotizing enterocolitis (NEC). Study intervention was stopped on completing 7 d, reaching enteral feeds of 100 mL/kg/d–1, or the appearance of any sign of FI or NEC. All neonates tolerated the test solution well. The SAF group reached significantly larger volume and higher calories on days 3 and 7 (P < 0.05 for all). No statistical differences were seen between the two groups in incidence of FI (P = 0.311), NEC (P = 0.429), mortality (P = 0.632), length of stay (P = 0.744), or weight gain on day 10 (P = 0.389). Baseline hematologic parameters showed no statistical differences before or after enteral administration (P > 0.05). Results of the present study demonstrated that SAF solution might improve feeding tolerance in VLBW babies without evidence of its systemic absorption. Larger multicenter randomized studies are recommended.