Clinical trial NCT02687685: Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Feeding
Keywords: Skin to Skin Contact
Infant, Newborn
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 300
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Exclusive human lactation
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Human lactation capacity in the newborn
timeFrame: within the first 24 hours of life
measure: Maternal satisfaction with breastfeeding
timeFrame: First 24 hours
measure: Evolution of birth weight
timeFrame: First week of life
measure: The need for hospitalization in the neonatal care unit
timeFrame: First week of life
Other outcomes:
Locations:
city: Zipaquirá
country: Colombia
facility: Hospital Universitario de la Samaritana Unidad Funcional Zipaquira
state: Cundinamarca
Study officials:
References:
citation: Agudelo SI, Molina CF, Gamboa OA, Acuna E. Comparison of the Effects of Different Skin-to-Skin Contact Onset Times on Breastfeeding Behavior. Breastfeed Med. 2021 Dec;16(12):971-977. doi: 10.1089/bfm.2021.0134. Epub 2021 Sep 7.
citation: Agudelo SI, Gamboa OA, Acuna E, Aguirre L, Bastidas S, Guijarro J, Jaller M, Valderrama M, Padron ML, Gualdron N, Obando E, Rodriguez F, Buitrago L. 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. Int Breastfeed J. 2021 Apr 13;16(1):33. doi: 10.1186/s13006-021-00379-z.
citation: Agudelo S, Gamboa O, Rodriguez F, Cala S, Gualdron N, Obando E, Padron ML. 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 Clinica Universidad de La Sabana: study protocol for a randomized clinical trial. Trials. 2016 Oct 26;17(1):521. doi: 10.1186/s13063-016-1587-7.