Breast Feeding Clinical Trial
Official title:
Randomized Clinical Trial of Immediate Skin to Skin Contact (SSC) at Birth, Early vs. Immediate, on the Duration of Exclusive Human Lactation in Full-term Newborns Treated at the Universidad de La Sabana Clinic
SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and
maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period
strategy that has proven to benefit the initiation and continuation of human lactation and
decreased hospitalization during the first week of life. This study aims to determine the
effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term newborns
treated at Universidad de La Sabana Clinic, on the duration of exclusive human lactation.
Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the
duration of exclusive human lactation in full-term newborns treated at the Universidad de La
Sabana Clinic?
Methodology: A random blind clinical trial was performed in which full-term healthy newborns
that are attended at the Universidad de La Sabana Clinic are included. The blind participants
will be those persons measuring the results and analysing the data. The sample size is
calculated for a type I error of 5%, a two tailed type II error of 20%, therefore estimating
percentage losses of 30%; 150 infants were included per 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 human lactation at 6 months. For continuous
variables, the Student t- test will be used for independent samples or the Wilcoxon rank sum
test, in case the assumptions of normality for the t-tests are not fulfilled. The assumption
of normality will be evaluated with the Shapiro Wilk and Kolmogorov-Smirnov test. Categorical
variables in contingency tables will be constructed, assessing independence between variables
with the Chi-square test or Fisher's exact test when the assumption of the number of cases is
not met by the cells in the contingency tables, times two. It will be calculated as a
measurement of the effect of relative risk (RR) with confidence intervals; the adjusted
measurements will be calculated using a multivaried regression Poisson model, variables with
significant results will be used in the bivariate analysis and those with biological
plausibility 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 the data analysis. An interim
analysis will be performed upon submission of half of the expected events (106), setting
limits for early termination of the trial according to the method proposed by Pampallona and
Tsiatis (1994).
Intervention: There will be 2 SSC randomization groups, early vs. immediate. After completing
the neonatal adaptation process and according to the group assignment, it will proceed to
leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT scale will
be applied. Monitoring will initially be performed with a face valuation between 3 and 10
days of life, then monthly telephone calls for 6 months to verify the status of human
lactation.
Results: To determine whether early versus immediate SSC has an impact on the duration of
exclusive human lactation.
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