Randomized, multicenter trial of two different formulas for very early enteral feeding advancement in extremely-low-birth-weight 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.
Mihatsch
W A
WA
Division of Neonatology and Pediatric Critical Care Medicine, Department of Pediatrics, University of Ulm, Ulm, Germany.
von Schoenaich
P
P
Fahnenstich
H
H
Dehne
N
N
Ebbecke
H
H
Plath
C
C
von Stockhausen
H B
HB
Gaus
W
W
Pohlandt
F
F
D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007225:Infant Food; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight / Q000254:growth & development* / Q000378:metabolism; D007363:Intensive Care Units, Neonatal; D007785:Lactose / Q000008:administration & dosage*; D008297:Male; D008895:Milk, Human; D011897:Random Allocation; D015430:Weight Gain
D007785:Lactose