Support Protocol for Face-to-face and Teleservice Breastfeeding for Puerperal Women and Mothers of Babies With Congenital Heart Disease: a Randomized Clinical Trial
| Registry | NCT06025864 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 72 (Estimated) |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul (Other); collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre |
| Conditions | Breastfeeding, Congenital Heart Disease |
| Interventions | Breastfeeding (Other) |
| Dates | start 2022-07-01, primary completion 2023-12-20 (estimated), completion 2024-02-20 (estimated), first posted 2023-09-06, last updated 2023-09-06 |
| Locations | 1 site in Brazil |
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All trials for Breastfeeding All trials for Congenital Heart Disease All trials of Breastfeeding
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Other: Breastfeeding | Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject. |
| Control Group | No intervention | 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. |
Sex: All, ages: 1 Day to 3 Days
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Juliana Caprini | Caxias do Sul, Rio Grande do Sul | Brazil | Recruiting |