The Effect of Breast Milk Cells on the Clinical Outcomes of Neonates With Birth Weight Equal to or Less Than 1800 Grams: a Randomized Controlled Trial

Abstract Background: Most premature and very low birth weight infants cannot tolerate feedings in the first few days of life and are deprived of breast milk's beneficial effects. This study aims to evaluate the breast milk cells' effects on neonates' clinical outcomes with a birth weight of ≤1800 grams.Methods: This research is a randomized controlled trial conducted on 156 infants in the neonatal intensive care unit of Mahdieh maternity Hospital in Tehran, Iran, from May 2019 to April 2020. All neonates with a birth weight of ≤1800 grams were enrolled and randomly divided into intervention and control groups. During the first 6-12 hours of delivery, neonates in the intervention group received the extracted breast milk cells (BMCs) provided by centrifuging their own mothers' breast milk for one time. Demographic data and clinical outcomes were compared between the two groups. We also had a subgroup analysis in neonates with birth weight less than 1500 grams.Results: A total of 156 neonates entered the final analysis. We divided participants into two groups by using a computer-generated block randomization sequence, including 75 patients in the intervention group and 81 neonates in the control group. The mean birth weight of neonates was 1390.1±314.4 grams, with a total mortality rate of 12.2% (n=19). We found that in-hospital mortality was significantly lower in neonates who received BMCs (6.7% vs. 17.3%; P-value: 0.043) compared to the control group, and it was more prominent in neonates with birth weight less than 1500 grams (9.5% vs. 30.2%; P-value: 0.017). We did not find any other significant differences in major complications such as retinopathy of prematurity, necrotizing enterocolitis, and bronchopulmonary dysplasia between the two groups.Conclusion: Our research demonstrated a significantly lower mortality rate in neonates (with a birth weight of ≤1800 grams) who received breast milk cells on the first day of life. Since this is a novel method with minimal intervention, we are looking forward to developing and evaluating this method in larger studies, with more frequent use of BMCs in very low birth weight infants.Trial registration: Iranian Registry of Clinical Trials, IRCT20190228042868N1. Registered 25 May 2019, https://irct.ir/trial/38230.