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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacion Profesor Novoa Santos

About this trial

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 criteria

Qualifiers

Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing specialist at 36 weeks of gestation.

Mothers who plan to give birth at HMI of CHUAC, referred from the C.S. Ventorrillo.

Women who are fluent in Spanish or Galician.

Disqualifiers

Maternal age under 18 years - Maternal use of drugs or medication that prevent breastfeeding .

Maternal infection with HIV or Human T-cell Leukemia Virus.

Mothers of newborns with cow's milk protein allergy, galactosemia, or congenital primary lactase deficiency.

Trial design

Treatments tested in this trial

  • breastfeeding counseling

Treatment groups

160 Participants
are divided into 2 treatment groups