Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
- Conditions
- Breast Feeding
- Registration Number
- NCT02687685
- Lead Sponsor
- Universidad de la Sabana
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Infants of mothers who express before the birth, their desire to breastfeed their newborn baby.
- Infants born between 7:00 am and 5:00 pm Monday through Friday in the USC.
- Full-term newborns defined by obstetric method and confirmed by paediatric method (Ballard), between 37 and 42 weeks of gestation, with appropriate weight for gestational age (between 10th and 90th percentiles for gestational age).
- Vaginal birth.
- Do not require basic or advanced neonatal resuscitation manoeuvres.
- Healthy and stable cardiorespiratory at birth.
- Have been permitted to room with the mother.
- Mothers and newborns that present absolute or relative contraindications for human lactation.
- Multiple births and pregnancies.
- Mothers with postpartum complications that limit the onset of human lactation.
- Major congenital malformations that prevent human lactation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Exclusive human lactation Through study completion, an average of 6 months Exclusive human lactation for 3 or more months. Exclusive human lactation is defined as: the time in months of human lactation as the only food source without having received other liquids or solid foods (except drugs and / or vitamins)
- Secondary Outcome Measures
Name Time Method Maternal satisfaction with breastfeeding First 24 hours Maternal satisfaction with breastfeeding in the first 24 hours according to the IBFAT Scale
Human lactation capacity in the newborn within the first 24 hours of life Human lactation capacity in the newborn within the first 24 hours of life by IBFAT Scale
The need for hospitalization in the neonatal care unit First week of life The need for hospitalization in the neonatal care unit in the first week of life.
Evolution of birth weight First week of life Evolution of birth weight in the first week of life.
Trial Locations
- Locations (1)
Hospital Universitario de la Samaritana Unidad Funcional Zipaquira
🇨🇴Zipaquirá, Cundinamarca, Colombia
Hospital Universitario de la Samaritana Unidad Funcional Zipaquira🇨🇴Zipaquirá, Cundinamarca, Colombia