Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial.
To compare the effect of initiating human milk fortification at 2 different feeding volumes on feeding intolerance and the time to reach full feeding volume.



Very low birth weight infants (n = 100) were prospectively randomized to early fortification (EF) (beginning at a feeding volume of 20 mL/kg/d) or delayed fortification (at a feeding volume of 100 mL/kg/d). We employed a standardized feeding protocol and parenteral nutrition guidelines for the nutritional management of all study infants.



The median days to reach full feeding volumes were equivalent in the 2 groups (20 vs 20, P = .45). No significant difference was observed in the total number of episodes of feeding intolerance (58 vs 57). Two cases of necrotizing enterocolitis (Bell stage ≥2) and deaths occurred in each group. Median daily protein intake (g/kg/d) was higher in EF group in week 1 (3.3 [3.2, 3.5] vs 3.1 [2.9, 3.3], P < .001), week 2 (3.6 [3.5, 3.8] vs 3.2 [2.9, 3.4], P < .001), and week 3 (3.7 [3.4, 3.9] vs 3.5 [2.8, 3.8], P = .006). Cumulative protein intake (g/kg) in the first 4 weeks of life was higher in EF group (98.6 [93.8, 104] vs 89.6 [84.2, 96.4], P < .001).



Very early human milk fortification may improve early protein intake in very low birth weight infants without increasing frequencies of adverse events.



ClinicalTrials.gov: NCT01988792.
Department of Pediatrics, University of Florida, Jacksonville, FL. Electronic address: sdshah_5@yahoo.com.
Sanket D
SD
Shah
Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN.
Narendra
N
Dereddy
Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN; Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN.
Tamekia L
TL
Jones
Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN; Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN.
Ramasubbareddy
R
Dhanireddy
Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN; Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN.
Ajay J
AJ
Talati
D004044:Dietary Proteins; D002149:Energy Intake; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D008297:Male; D008895:Milk, Human; D011446:Prospective Studies; D013997:Time Factors; D015430:Weight Gain
D004044:Dietary Proteins
caloric intake; growth; protein intake