Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial

Objective. A prospective, double-blind, randomized, controlled trial was co nducted to evaluate the growth and nutritional status of preterm infants re ceiving preterm human milk supplemented with a newly formulated powdered hu man milk fortifier (HMF), study fortifier (SF), or a powdered commercial HM F (CF). Methods. Infants (n = 144) with a birth weight less than or equal to 1600 g and gestational age at birth of less than or equal to 33 weeks were enroll ed and randomized before 21 days of life. Study day (SDAY) 1 was defined as the day full-strength fortification (4 packets/100 mL) began and the infan t reached an intake of at least 100 mL/kg/day. Growth, biochemical indices of nutritional status, enteral intake, feeding tolerance, clinical historie s, and morbidity were assessed serially. The primary outcome variable was w eight gain (g/kg/day) from SDAYs 1 to 29 or hospital discharge, whichever c ame first. Results. Infants fed human milk supplemented with SF consistently grew more rapidly from SDAYs 1 to 29 (or hospital discharge), regardless of whether the statistical analyses were performed on all subjects who were randomized into the study and reached SDAY 1 (intent-to-treat) or were limited to tho se able to adhere strictly to the feeding protocol of the study (subgroup). Using mean values adjusted for study site (least square [LS] means), the w eight gain differences were 2.6 and 3.8 g/kg/day for the intent-to-treat an d subgroup analyses, respectively. Likewise, the length-gain differences we re .14 and .18 cm/week for the intent-to-treat and subgroup analyses, respe ctively. Infants in the SF group reached a weight of 1800 g at SDAY 18, and those in the CF group at SDAY 25. Mean alkaline phosphatase values among i nfants in the SF group were higher than for the CF infants (eg, LS means: 3 27 U/L vs 272 U/L, intent-to-treat analysis), likely reflecting the more ra pid linear growth of the SF infants. Mean serum calcium values tended to be lower in the SF group in the intent-to- treat analysis and were significan tly lower in the subgroup analysis (LS means: 10.3 mg/dL vs 11.2 mg/dL). Bo th fortifiers were generally well-tolerated, although an increased number o f infants in the CF group exited the feeding protocol because of gastric re siduals and abdominal distention. Conclusion. A new powdered HMF was shown to enhance the growth of preterm i nfants, compared with a commercially available powdered HMF in the United S tates.