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Clinical Trial
. 2001 Aug;33(2):155-9.
doi: 10.1097/00005176-200108000-00011.

Randomized, multicenter trial of two different formulas for very early enteral feeding advancement in extremely-low-birth-weight infants

W A Mihatsch  1 , P von Schoenaich, H Fahnenstich, N Dehne, H Ebbecke, C Plath, H B von Stockhausen, W Gaus, F Pohlandt
Affiliations
Clinical Trial

Randomized, multicenter trial of two different formulas for very early enteral feeding advancement in extremely-low-birth-weight infants

W A Mihatsch et al. J Pediatr Gastroenterol Nutr. 2001 Aug.

Erratum in

  • J Pediatr Gastroenterol Nutr 2002 Nov;35(5):739

Abstract

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.

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