Neonatal Clinical Trials
Neonatal Clinical Trials 1
Tanith Alexander, PhD (she/her/hers)
Advanced Clinical Neonatal Dietitian
Liggins Institute and Te Whatu Ora Counties Manukau
Auckland, Auckland, New Zealand
To investigate the impact of different feeding strategies on feed tolerance and body composition in MLPT babies.
Design/Methods: We undertook a multi-centre, factorial, randomized, controlled trial in babies born 32+0 – 35+6 weeks’ gestation with intravenous (IV) access whose mothers intended to breastfeed, randomizing babies to combinations of three factors until full milk feeds were established: (1) IV amino acid solution vs. IV dextrose; (2) milk supplement vs. exclusive mother’s own milk (MOM), and (3) exposure to taste/smell or not before gastric tube feeds. The primary outcome for factors 1 and 2 was fat mass % at 4 months’ corrected age, analyzed using linear regression models adjusted for hospital site, gestation and sex, and for factor 3, days to full enteral feeds (defined as 150 mL.kg−1.day−1 or exclusive breastfeeding, whichever occurred first), analyzed using Cox proportional hazard models. All analyses were controlled for the non-independence of multiple births using a cluster effect.
Results: 532 babies were recruited from 2017 to 2022 (55% boys). Primary outcomes were assessed in 526 (99%) babies at discharge and 324 (61%) at 4 months’ corrected age. % fat mass at 4 months’ corrected age was not different between babies given IV amino acids or dextrose (factor 1) [mean(standard deviation, SD) 26.0(5.4) vs 26.2(5.2)%, p=0.7] or between babies given milk supplement vs MOM (factor 2) [26.3(5.3) vs 25.8(5.4)%, p=0.3]. Time to full enteral feeds was not different between babies exposed or not exposed to taste/smell [mean(SD) 5.8(1.5) vs 5.7(1.9) days, p=0.6]. There also was no difference in the time to full enteral feeds for factor 1 [5.7(1.7) vs 5.8(1.8) days, p=0.6] or factor 2 [5.7(1.7) vs 5.8(1.7) days, p=0.1]. Time to discharge home was similar between groups [overall 24.8(11.4)].
Conclusion(s): Provision of parenteral nutrition or formula in addition to MOM does not affect body composition at 4 months’ corrected age. Early nutritional support strategies do not affect time to full enteral feeds or days in hospital. Providing breastmilk only should be the goal for the nutritional management of MLPT babies.