Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart Disease

Instituto de Cardiologia do Rio Grande do Sul

Status: Enrolling

Conditions: Breastfeeding; Congenital Heart Disease

Treatments: Other: Breastfeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06025864

5947.21

Details and patient eligibility

About

To evaluate the effect of applying a hybrid protocol (face-to-face and via call center) of breastfeeding assistance and guidance on the duration of breast milk supply to babies with congenital heart disease for 6 months.

Full description

The objective of this randomized, multicenter clinical trial is to evaluate the effect of applying a hybrid protocol (face-to-face and telemarketing) of assistance and guidance on breastfeeding and duration of breast milk supply for infants with congenital heart disease in the first 6 months of life. Recruitment of infants diagnosed with congenital heart disease occurs within the first 72 hours of life, being followed up for 6 months.

Initially, the mothers in the control group, as well as the mothers in the intervention group, receive a booklet with guidelines on breastfeeding, a standardized measuring cup for milk collections and a breastfeeding booklet.

In addition, mothers in the intervention group receive monthly videos with guidance on breastfeeding, monthly consultations with a breastfeeding consultant and a support group via whatsapp with the researcher and scientific initiation student until the baby is 6 months old.

Enrollment: 72 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants diagnosed with congenital heart disease,
• The parents must have a cell phone enabled to receive video calls.

Exclusion criteria

• Mothers carriers of the human immunodeficiency virus (HIV),
• Mothers users of medications without medical indication to initiate or maintain breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.

Treatment:

Other: Breastfeeding

Control Group

No Intervention group

Description:

All mothers were followed up for 6 months and received a breastfeeding support booklet virtually, through a cell phone application. The booklet provides basic information about breastfeeding and possible complications. The recruited mothers also received a notebook to record the date, duration, volume and frequency of breastfeeding and/or milk collections, and the use of alternative routes such as a bottle, cup or enteral nutrition. At the initial visit, all mothers were given a standard measuring cup to measure the volume of milk used up in the household each day. In addition, all mothers received a call 7 days after delivery to apply the Portuguese version of the Breastfeeding Self-Efficacy Survey - Short Form: BSES-SF. This questionnaire was reapplied after 90 days.