Interim analysis of a randomized clinical trial of early versus immediate skin-to-skin contact in term infants

Abstract

Introduction: Skin-to-skin contact (STSC) at the birth of the mother-newborn (NB) binomial has a positive impact on achieving exclusive breastfeeding (BF), however, the effectiveness and safety of the STSC given immediately or when it occurs early (one hour after birth) is unknown. Objective: To conduct the interim analysis of a randomized clinical trial (RCT), which compares the STSC immediate vs STSC early, to determine which is more effective (rate of exclusive BF in the first three months of life) and safe (neonatal physiological stability and complications). Material and methods: RCT carried out in two hospitals in Colombia, from November 2018 to July 2019. At-term healthy newborns were included. Safety was assessed in the neonatal period, by monitoring vital signs. Regarding BF, what happened in the first 24 hours was recorded; later, the mothers were contacted by telephone after one week of life and monthly. Results: 150 patients were evaluated, 75 in each STSC group. No statistically significant differences were found in the frequency of exclusive breastfeeding at any of the moments evaluated. There were also no complications in the two study groups. Conclusions: At half the calculated sample size of the RCT, the interim analysis shows that there is no difference in terms of effectiveness hic and safety or between mx immediate and early CPP, thus there is no ethical objection to continuing patient recruitment. Therefore, this RCT can be completed, as originally planned.