Shorter time to full enteral feedings among infants fed an intact protein (IP) vs an extensively hydrolyzed (EH) formula does not appear to be related to differences in gastric emptying

Shorter time to full enteral feedings among infants fed an intact protein (IP) vs an extensively hydrolyzed (EH) formula does not appear to be related to differences in gastric emptying Maria Elisabetta Baldassarre1, Antonio Di Mauro2, Margherita Fanelli3, Osvaldo Montagna1, Jennifer Wampler4, Timothy Cooper4, Nicola Laforgia5 1University of Bari-Policlinico Hospital, Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Bari, Italy 2University of Bari "Aldo Moro", Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Bari, Italy 3University of Bari "Aldo Moro", Department of Interdisciplinary Medicine, Bari, Italy 4Mead Johnson Nutrition, Department of Medical Affairs, Evansville, United States 5University of Bari "Aldo Moro" , Department of Biomedical Science and Human Oncology, Bari, Italy Objectives and study: Hydrolyzed cow’s milk protein infant formulas are often used in preterm infant feeding despite little clinical evidence of improvement in feeding advancement or markers of feeding tolerance. An objective of the current study was to evaluate the relationship of days to full feeding with gastric emptying time in preterm infants randomly assigned to receive one of two marketed study formulas for the first 14 feeding days. Methods: In this double-blind, controlled, parallel-group, prospective study, eligible infants (28-33 weeks’ gestational age; birth weight of 700-1750g and AGA) were enrolled within 24 hours of first enteral feeding. All mothers were encouraged to provide their own breast milk; study formula was supplemented as needed per randomization. The primary outcome was days to full enteral feeding (≥140 mL/kg/day). Gastric emptying rate and half-emptying time (T1/2) were assessed by real-time ultrasonography on Study Day 14 using antral measurements from 0 (before bolus) to 90 min (15-min intervals). Populations for analysis included participants who 1) completed the study per protocol and 2) received ≥75% study formula intake. Results: Of 65 enrolled preterm infants (IP: n=32; EH: n=33), 60 completed the study per protocol (IP: 30; EH: 30); of these, 54 (90%) received some breast milk and 23 received ≥75% study formula intake (IP: 11; EH: 12). Median time to achievement of full feeding was significantly shorter for the IP vs EH group (Day 10 vs 14, P=0.030) for participants receiving ≥75% study formula intake. Achievement of full enteral feeding by Day 14 was similar between groups overall (IP: 24/30, 80%; EH: 19/30, 63%; P=0.121), but higher in the IP group for participants receiving ≥75% study formula intake (IP: 10/11, 90.9%; EH: 6/12, 50% P=0.069). Median gastric emptying at Day 14 was significantly slower for the IP vs EH group overall (T1/2; 59 vs 54 min; P=0.031) and in participants who received ≥75% study formula intake (62 vs 53 min, P=0.018). However, gastric emptying time had no correlation with achievement of full feeding for participants who completed the study per protocol (r2=0.008; P=0.49) (Figure). No group differences were detected in tolerance measures (abdominal distention, regurgitation/emesis, feedings withheld ≥4h, or bloody stools) or in positive cultures for sepsis (IP: 2, EH: 3; evaluations performed in 63.3% of participants). No episodes of NEC were reported. Vol. 64, Supplement 1, April 2017 920 Fig: Conclusion: Feeding intact cow milk protein formula vs extensively hydrolyzed casein formula was associated with shorter time to full enteral feeding. However, faster emptying with extensively hydrolyzed formula did not predict feeding success, raising questions around the clinical relevance of this surrogate marker of feeding tolerance.