NCT06025864

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Instituto de Cardiologia do Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Breastfeeding
• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Breastfeeding	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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-20
• Completion: 2024-02-20
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: Brazil