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Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
Maria Elisabetta Baldassarre1, Antonio Di Mauro2, Margherita Fanelli3
1Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari "Aldo Moro", Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy. mariaelisabetta.baldassarre@uniba.it.
Insights
Intact protein preterm formula (IPF) led to faster full enteral feeding in preterm infants compared to extensively hydrolyzed formula (EHF). This study highlights IPF
Area of Science:
- Neonatal Nutrition
- Pediatric Gastroenterology
- Infant Formula Research
Background:
- Preterm infants often require specialized nutritional support.
- Evaluating different formulas is crucial for optimizing growth and development.
- Enteral feeding tolerance and advancement are key concerns in neonatal care.
Purpose of the Study:
- To compare enteral feeding advancement and tolerance in preterm infants.
- To assess the efficacy of intact protein preterm formula (IPF) versus extensively hydrolyzed formula (EHF).
- To determine the time to achieve full enteral feeding and overall tolerance.
Main Methods:
- A comparative study involving preterm infants receiving either IPF or EHF for 14 days.
- Primary outcome: days to achieve full enteral feeding (≥140 mL/kg/day).
- Secondary analyses included tolerance measures and proportion of infants receiving ≥75% study formula.
Main Results:
- No significant differences in general tolerance measures between the two formula groups.
- Median time to full enteral feeding was significantly shorter for IPF (10 days) compared to EHF (14 days).
- Mean enteral intake increased significantly by day 14 in the IPF group.
Conclusions:
- Intact protein preterm formula (IPF) may facilitate quicker advancement to full enteral feeding in preterm infants.
- IPF demonstrated a trend towards higher feeding volumes achieved by study end compared to EHF.
- Further research can explore long-term outcomes and specific indications for each formula type.
Background:
This study was carried out to evaluate enteral feeding advancement and tolerance in preterm infants receiving one of two marketed formulas: intact protein preterm formula (IPF) or extensively hydrolyzed formula (EHF) for the first 14 feeding days.
Methods:
Primary outcome was days to full enteral feeding (≥140 mL/kg/day). Per protocol analyses included the following: all participants who met study entrance criteria and completed study feeding (primary) and those who received ≥75% enteral intake from study formula (subset). Mothers were encouraged to provide their breast milk.
Results:
Of the 65 enrolled (IPF: n = 32; EHF: n = 33), 60 completed study feeding per protocol (IPF: n = 30; EHF: n = 30), 37 (62%) received predominantly breast milk, and 23 (38%) received ≥75% study formula intake (IPF: n = 11; EHF: n = 12). No group differences were detected in tolerance measures. No necrotizing enterocolitis (NEC) was reported. Median time to achievement of full enteral feeding was significantly shorter for the IPF vs. EHF group (day 10 vs. 14, p < 0.05) (subset analysis). Mean enteral intake significantly increased by day 14 for the IPF group (p < 0.05), reflecting group divergence as achieved feeding volumes increased.
Conclusions:
Results suggest shorter time to full enteral feeding and higher feeding volume achieved by study end in preterm infants receiving intact protein preterm formula versus extensively hydrolyzed formula.
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