Health TrialsbyHealthPanel

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

ConditionsGrowth & DevelopmentBreastfeeding SatisfactionBreastfeeding Consultancy TrainingBreastfeeding DurationBreastfeeding After Discharge From Hospital Following Childbirth, Yes/noBreastfeeding, ExclusiveBreastfeeding AttitudeBreastfeeding Support SystemBreastfeeding RateBreastfeeding Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundación Pública Galega de Investigación Biomédica INIBIC

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

This trial does not accept healthy volunteers

Qualifiers

Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing or Physician 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.

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Trial design

Design model

Parallel

Treatments tested in this trial

  • breastfeeding counseling

    Behavioral

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Conventional careNo intervention 0 interventions
Group B: breastfeeding counselingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of exclusive breastfeeding at 6 months of age of the newborn

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.

Time frame
From birth up to 6 months of the infant's life

Secondary outcomes

1

Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life.

Defined as the practice of feeding the infant exclusively with breast milk (without giving any other food or drink, not even water). Breastfeeding by a wet nurse, feeding with expressed breast milk, and feeding with donor breast milk are also considered breastfeeding.

Time frame
At 15 days, one month, and three months of the newborn's life.
2

Number of participants with recovery to birth weight

The infant regains the weight with which they were born

Time frame
At 15 days and one month of age
3

Grams of daily weight gain

Grams of weight gained per day since the previous weight check.

Time frame
At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life
4

Age of introduction of complementary feeding

Age of the infant at which complementary feeding is started in both study groups.

Time frame
From birth to 6 months of age

Other outcomes

Sponsors and contacts

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Fundación Pública Galega de Investigación Biomédica INIBIC

Lead sponsor

Source ClinicalTrials.gov
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