Randomized clinical trial of the effect of the onset time of skin-to-skin contact at birth, immediate compared to early, on the duration of breastfeeding in full term newborns.

BACKGROUND: Skin-to-skin contact (SSC) compared to separation at birth has a positive effect on breastfeeding. However, separation at birth is common with negative impact on breastfeeding. The aim was to determine the effect of immediate SSC compared to early SSC on the duration of exclusive breastfeeding. METHODS: A randomized multicentre parallel clinical trial was conducted in two hospitals in Cundinamarca (Colombia) between November 2018 and January 2020. Low-risk full term newborns at birth were included. Neonates were assigned to immediate (in the first minute after birth) or early onset (start exactly at 60 min of life) skin to skin contact. Monthly follow-up was performed until 6 months of age. The primary outcome was the percentage of exclusively breastfed infants at 6 months (time in months with human milk as the only source of food). Secondary outcomes were the percentage of infants with exclusive breastfeeding at 3 months, duration in months of exclusive breastfeeding, neonate's breastfeeding ability, percentage of weight change between birth and the first week of life and hospitalization in the neonatal unit in the first week. A bivariate analysis was performed to determine the variables associated with exclusive breastfeeding at 6 months. A survival analysis was performed to evaluate the effect of the onset of SSC on exclusive breastfeeding duration. RESULTS: A total of 297 newborns were included: 49.8% (n = 148) in the immediate SSC group, and 50.2% (n = 149) in the early SSC group. The mean duration of exclusive breastfeeding in both groups was 5 months. There were no differences between the groups in the percentage of exclusive breastfeeding at 6 months (relative risk [RR] 1.06, 95% CI 0.72, 1.58) or in the duration of exclusive breastfeeding (hazard ratio [HR] 0.98, 95% CI 0.74, 1.28). CONCLUSIONS: The percentage of infants and the duration of exclusive breastfeeding in the first 6 months of age were the same between the two groups of SSC interventions. Given the current barriers to its implementation, the results of this study could positively impact the use of SSC at birth and standardize the intervention and improve breastfeeding indicators. TRIAL REGISTRATION: ClinicalTrials.gov NCT02687685 .

The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clínica Universidad de La Sabana: study protocol for a randomized clinical trial.

BACKGROUND: Human lactancy is a simple and cost-effective strategy that influences infant and maternal mortality rates. Skin-to-skin contact (SSC) is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and to decrease hospitalization during the first week of life. This study aims to determine the effect of SSC initiation at birth (immediate versus early) in healthy, full-term newborns treated at the Universidad de La Sabana Clinic on the duration of exclusive human lactation. METHODS/DESIGN: A randomized, blind clinical trial will be performed with full-term healthy newborns born at the Universidad de La Sabana Clinic. The blind trial participants will be those persons measuring the results and analyzing the data. The sample size will be calculated for a type I error of 5 %, a two-tailed type II error of 20 %, and an estimated percentage loss of 30 %; 150 infants will be included in each group. Randomization will be performed using permuted, size-6 blocks. Descriptive analysis will be conducted using central tendency and dispersion measurements. A bivariate analysis will be performed to determine which variables are associated with exclusive lactancy at 6 months. For continuous variables, Student's t test will be used for independent samples, and the Wilcoxon rank sum test will be used if the assumptions of normality for the t tests are not fulfilled. The assumption of normality will be evaluated using the Shapiro-Wilk and Kolmogorov-Smirnov tests. Categorical variables in contingency tables will be constructed to assess the independence between variables using the chi-square test, or Fisher's exact test when the assumption of the number of cases is not met by the values in the contingency tables multiplied by two. This will be calculated as a measurement of the effect of relative risk (RR) with confidence intervals; the adjusted measurements will be calculated using a multivariate regression Poisson model. Variables with significant results will be used in the bivariate analysis, and those with biological plausibility will be used for the adjustment. The analysis will be carried out for a two-tailed type I error level of 5 %. The Stata 11 program will be used for data analysis. An interim analysis will be performed upon the submission of half the expected events (106), setting limits for the early termination of the trial according to the method proposed by Pampallona and Tsiatis (1994). INTERVENTION: There will be two SSC randomization groups: early versus immediate. After completing the neonatal adaptation process and based on the group assignment, the mother will be left with her newborn child in hospital accommodation. Prior to discharge, the Infant Breast-Feeding Assessment Tool (IBFAT) will be applied. Monitoring will initially be performed with a face-to-face assessment between 3 and 10 days of life, followed by monthly telephone calls for 6 months to verify lactation status. DISCUSSION: SSC at birth has shown benefits in the short and long term for both the mother and the full-term newborn. Although the meta-analysis that have been done have shown the benefits of this technique, multiple differences in the SSC interventions have been identified because criteria such as the initiation or duration of SSC (dose) have not been unified. Colombia has a malnutrition risk of 11,4 % in the total population for the period 2012-2014, so it is necessary to promote strategies that generate a positive impact on the duration of human lactation, providing support from the clinical setting of humanized delivery which is included in the IAMI strategy (Instituciones Amigas de la Mujer y la Infancia - Friends of Women and Children Institution). Therefore, we propose that the initiation time of SSC in full-term new-borns is related to the duration of exclusive human lactation. TRIAL REGISTRATION: Registered ClinicalTrials.gov Identifier: NCT 02687685 . Registered on 2 February 2016. This study is not yet open for participant recruitment.