Abstract
Objectives: To evaluate the relationship between gastric emptying (GE) time and days to achievement of full enteral feeding (≥140 mL/kg/day) in preterm infants randomly assigned to receive one of two marketed study formulas for the first 14 feeding days: intact protein premature formula (IPF) or extensively hydrolyzed protein (EHF) formula. Methods: In this triple-blind, controlled, prospective, clinical trial, we report GE time (time to half-emptying, t1/2) by real-time ultrasonography on Study Day 14, in preterm infants receiving IPF or EHF formula. The association between GE time and achievement of full enteral feeding was evaluated by Pearson correlation. Per-protocol populations for analysis included participants who (1) completed the study (overall) and (2) who received ≥ 75% study formula intake (mL/kg/day). Results: Median GE time at Day 14 was significantly faster for the EHF vs. IPF group overall and in participants who received ≥ 75% study formula intake (p ≤ 0.018). However, we demonstrated GE time had no correlation with the achievement of full enteral feeding (r = 0.08; p = 0.547). Conclusion: Feeding IP premature formula vs. EH formula was associated with shorter time to full enteral feeding. However, faster GE time did not predict feeding success and may not be a clinically relevant surrogate for assessing feeding tolerance.
Highlights
When a mother’s own breast milk or donor breast milk is not available, there is a desire to select infant formulas that would minimize both fasting and the time to achieving full enteral nutrition while considering the potential for necrotizing enterocolitis (NEC) and related morbidities often associated with feeding difficulties
In the current pilot study, we evaluate the correlation between Gastric Emptying (GE) time and the achievement of full enteral feeding in preterm infants randomly assigned to receive one of two cow’s milk-based study formulas over the first 14 days of feeding: intact protein premature infant formula (marketed Enfamil® Premature, Mead Johnson Nutrition (MJN), Evansville, IN, USA) or extensively hydrolyzed protein infant formula
Participants were enrolled in a triple-blind, randomized, controlled prospective pilot study to evaluate the achievement of full enteral feeding in premature infants randomized to receive one of two study formulas over the first 14 days of feeding: intact protein premature infant formula (IPF: marketed Enfamil® Premature, Mead Johnson Nutrition (MJN), Evansville, IN, USA) or extensively hydrolyzed protein infant formula (EHF: marketed Pregestimil®, MJN, Evansville, IN, USA)
Summary
When a mother’s own breast milk or donor breast milk is not available, there is a desire to select infant formulas that would minimize both fasting and the time to achieving full enteral nutrition while considering the potential for necrotizing enterocolitis (NEC) and related morbidities often associated with feeding difficulties. In the current pilot study, we evaluate the correlation between GE time and the achievement of full enteral feeding (defined as a daily intake of ≥ 140 mL/kg/day) in preterm infants randomly assigned to receive one of two cow’s milk-based study formulas over the first 14 days of feeding: intact protein premature infant formula (marketed Enfamil® Premature, Mead Johnson Nutrition (MJN), Evansville, IN, USA) or extensively hydrolyzed protein infant formula (marketed Pregestimil® , MJN, Evansville, IN, USA)
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