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

Support Protocol for Face-to-face and Teleservice Breastfeeding for Puerperal Women and Mothers of Babies With Congenital Heart Disease: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06025864
Enrollment
72
Registered
2023-09-06
Start date
2022-07-01
Completion date
2024-02-20
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Congenital Heart Disease

Keywords

breast milk, congenital heart desease, nutritional status, 6 months, call center

Brief summary

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.

Detailed 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.

Interventions

OTHERBreastfeeding

Over the 6 months of the intervention, 1 video per month was sent, a total of 6 videos, via the mobile application, with guidance on breastfeeding: the importance of maternal hydration; myths and truths about the mother's diet; practical guidance on breastfeeding; baby's gastric capacity; picking up and positioning the baby during breastfeeding and storing milk for the return to work. There were also 1 call per month, with an average duration of 15 minutes, with a breastfeeding consultant nutritionist, aiming to solve doubts and difficulties that month. In order to provide complete assistance, virtual groups were created via the WhatsApp application, with a nutritionist and a health academic to solve doubts, provide emotional support and exchange information when necessary. According to the region or municipality of origin of the mother-baby dyad, when necessary, this study provided the loan of a breast pump during the follow-up period or 6 months.

Sponsors

Irmandade Santa Casa de Misericórdia de Porto Alegre
CollaboratorOTHER
Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Multicenter Randomized Clinical Trial

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Breast milk supply rate during the baby's 6-month periodUp to 6 monthsIncrease milk supply directly from the mother's breast or through pumps for use in alternative routes.

Secondary

MeasureTime frameDescription
Compare the time of breastfeedingUp to 6 monthsCompare the time of offering the breast between the control group and the intervention group
Breastfeeding self-efficacy before and during the interventionUp to 6 monthsThe breastfeeding self-efficacy questionnaire in a reduced format (BSES-SF) will be applied in two moments during the infant's 6 months of life, and the effectiveness of the interventions can be observed. The score can vary from 1 to 70, where higher results reflect greater self-efficacy in breastfeeding.
Assessment of the nutritional status of infants at 6 months of age using the growth curves of the World Health Organization and classified according to the Z scoreUp to 6 monthsAssess the nutritional status of infants at 6 months of age through weight and height. These data will be placed on the nutritional assessment curves of the World Health Organization (WHO) and classified using the Z score. Afterwards, the results between the intervention and control groups will be compared.

Countries

Brazil

Contacts

Primary ContactJuliana Caprini, Esp
juli_caprini@yahoo.com(54)992044907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026