Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Condition(s) studied
Investigational drug(s) / intervention(s)
breastfeeding counseling: The intervention group will receive, in addition to the indicated conventional care, 4 scheduled breastfeeding counseling appointments, the first of which will take place within the first 72 hours after hospital discharge following birth. As part of the breastfeeding counseling, the Latch scale will be used to observe and assess breastfeeding sessions, the breastfeeding self-efficacy scale-short (BSES-SF) to evaluate breastfeeding self-efficacy, the Visual Analogue Scale (VAS) to evaluate pain related to breastfeeding, and the breastfeeding clinical record form from the World Health Organization (WHO). Training will be provided to the mother and family on pre-selected breastfeeding topics. Mothers will be able to contact the IP nurse by phone daily on demand from 10 a.m. to 3 p.m.
Study summary
Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother. Many breasfeeding are abandoned early due difficulties experienced after dischargue and after returning to work. Development specific early breastfeeding support programs in the community is necessary to avoid unwanted abandonment.
Objective: To analyse the differences in BF rates at six month of birth in healthy full-term newborns between the study groups.
Methodology: Pilot study of a randomised clinical trial carried out in a Paediatric Nursing clinic at the Ventorrillo Health Centre in A Coruña. The study population will be mothers of healthy full-term newborns who wish to give BF at the time of delivery and whose reference health centre is the one of the study. The mother- newborn dyads in the control group (CG) will receive the usual care described in the child health Program of the Galician Health Service, and the dyads included in the intervention group (IG) will also receive specific advice on breastfeeding during the first 6 months of life. A study sample of 80 participants is estimated for each group. The study will be approved by the Research Ethics Committee of A Coruña-Ferrol. The variables under study will be collected in a data collection notebook for later statistical analysis. A significant value of p \< 0.05 being considered.
Eligibility
Primary outcome measure(s)
- Rate of exclusive breastfeeding at 6 months of age of the newborn — From birth up to 6 months of the infant's life
The practice of feeding the infant exclusively with breast milk from 0 to 5 months (without giving any other food or drink, not even water). Nursing by a wet nurse, feeding with expressed breast milk, and feeding with breast milk from donors are also considered breastfeeding.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centro de Salud de O Ventorrillo | A Coruña | Galicia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07309510 on ClinicalTrials.gov ↗ ← All trials in Spain