Clinical Trial

Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center

Study acronym: ALM-AP
Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Sponsor changed: Fundacion Profesor Novoa Santos -> Fundación Pública Galega de Investigación Biomédica INIBIC 2026-07-12
Trial Details
NCT Number NCT07309510
Lead Sponsor Fundacion Profesor Novoa Santos
Conditions Growth & Development, Breastfeeding Satisfaction, Breastfeeding Consultancy Training, Breastfeeding Duration, Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no, Breastfeeding, Exclusive, Breastfeeding Attitude, Breastfeeding Support System +2 more
Enrollment 160 participants
Start Date 2026-01
Primary Completion 2026-08 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-08