Related Experiment Videos
Randomized, multicenter trial of two different formulas for very early enteral feeding advancement in
W A Mihatsch1, P von Schoenaich, H Fahnenstich
1Division of Neonatology and Pediatric Critical Care Medicine, Department of Pediatrics, University of Ulm, Ulm, Germany.
Insights
A new high-lactose formula (HLF) did not improve feeding volume in extremely-low-birth-weight (ELBW) infants compared to a low-lactose formula (LLF). Human milk significantly increased feeding volume and reduced necrotizing enterocolitis risk in ELBW infants.
Area of Science:
- Neonatal Nutrition
- Pediatric Gastroenterology
- Clinical Nutrition
Background:
- Extremely-low-birth-weight (ELBW) infants often require formula if human milk is unavailable.
- A novel high-lactose formula (HLF) was developed with low protein and phosphate content for early enteral feeding.
- This study compared the tolerance of HLF against a low-lactose formula (LLF) in ELBW infants.
Purpose of the Study:
- To evaluate if HLF enhances cumulative milk feeding volume (CFV) in ELBW infants compared to LLF.
- To determine if HLF provides at least a 20% increase in CFV in at least 60% of matched pairs.
- To investigate the impact of human milk supplementation on CFV in ELBW infants.
Main Methods:
- A randomized multicenter trial involved 99 ELBW infants starting at 48 hours of age.
- Infants were fed using a standardized protocol with daily 12 ml/kg increments.
- The primary outcome measured was the CFV between days 3 and 14.
Main Results:
- HLF feeding resulted in a CFV of 720 mL/kg, while LLF resulted in 613 mL/kg, with no significant 20% difference.
- Infants receiving >10% human milk had a higher CFV (832 mL/kg) than those receiving <10% (533 mL/kg).
- Necrotizing enterocolitis (Bell stage ≥2) occurred exclusively in the LLF group (n=5, P<0.05).
Conclusions:
- The study did not demonstrate the hypothesized 20% advantage of HLF over LLF for ELBW infant feeding.
- The findings support the hypothesis that human milk is the optimal initial diet for ELBW infants.
- Further controlled trials are needed to confirm the benefits of human milk in ELBW infants.
Background:
In extremely-low-birth-weight (ELBW) infants, formula feeding is required if human milk is not available. The tolerance of a new 'high' lactose (55 g/L), low protein, low phosphate, hydrolyzed protein formula (HLF) for early enteral feeding advancement of ELBW infants was compared with that of a low lactose (1 g/L) hydrolyzed protein formula (LLF).
Methods:
In a randomized multicenter trial, 99 ELBW infants were fed according to a standardized protocol beginning at 48 hours of age with 12 ml/kg daily increments. Primary outcome was the cumulative milk feeding volume (CFV) from days 3 to 14. The authors hypothesized that feeding HLF as a supplement to human milk would increase the CFV at least by 20% in at least 60% of matched pairs compared with LLF. A secondary issue was to investigate whether human milk would increase the CFV compared with formula.
Results:
The CFV was 720 mL/kg (range, 0-962 mL/kg) with HLF and 613 mL/kg (range, 3-1,283 mL/kg) with LLF feeding. There was no 20% difference. On day 14, the median feeding volume was 103 mL/kg. The CFV was 533 mL/kg (range, 0-962 mL/kg) in infants who received less than 10% of human milk and 832 mL/kg (range, 74-1,283 mL/kg) in infants who received more than 10%. Necrotizing enterocolitis (Bell stage > or =2) occurred only with LLF feeding (n = 5; P < 0.05).
Conclusions:
The study failed to find the hypothesized 20% advantage of the new HLF. The observed advantage of human milk supports the hypothesis that it should be the first diet in ELBW infants; however, this hypothesis still must be confirmed in a controlled, randomized trial.