Support for breastfeeding in 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
This study is testing a new way to support new moms in breastfeeding their babies with congenital heart disease by offering both in-person and phone help for six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul Academic / other |
| Locations | 1 site (Caxias do Sul, Rio Grande Do Sul) |
| Trial ID | NCT06025864 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a hybrid approach combining face-to-face and telephonic support to assist postpartum women in breastfeeding their infants diagnosed with congenital heart disease. The study involves providing mothers with educational materials, monthly video consultations, and a support group via WhatsApp for six months. The aim is to enhance the duration of breast milk supply for these infants during their critical early months of life. Participants are recruited within the first 72 hours after the infant's birth and are followed up for six months to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum mothers of infants diagnosed with congenital heart disease who have access to a cell phone for video calls.
Not a fit: Patients who may not benefit from this study include mothers who are HIV positive or those using medications that contraindicate breastfeeding.
Why it matters
Potential benefit: If successful, this approach could significantly improve breastfeeding duration and nutritional outcomes for infants with congenital heart disease.
How similar studies have performed: Other studies have shown success with similar breastfeeding support interventions, indicating potential for positive outcomes in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Caxias do Sul, Rio Grande Do Sul
- Juliana Caprini — Caxias do Sul, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Fernanda Lucchese-Lobato, PHD — Instituto de Cardiologia de Porto Alegre
- Study coordinator: Juliana Caprini, Esp
- Email: juli_caprini@yahoo.com
- Phone: (54)992044907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.