Clinical trial NCT06025864: Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart Disease
Official title: Support Protocol for Face-to-face and Teleservice Breastfeeding for Puerperal Women and Mothers of Babies With Congenital Heart Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Congenital Heart Disease
Keywords: breast milk
congenital heart desease
nutritional status
6 months
call center
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2023-09-06
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter Randomized Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Breast milk supply rate during the baby's 6-month period
timeFrame: Up to 6 months
Secondary outcomes:
measure: Compare the time of breastfeeding
timeFrame: Up to 6 months
measure: Breastfeeding self-efficacy before and during the intervention
timeFrame: Up to 6 months
measure: 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 score
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Caxias do Sul
country: Brazil
facility: Juliana Caprini
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia de Porto Alegre
name: Fernanda Lucchese-Lobato, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. 2013 Nov;98(5):1226-32. doi: 10.3945/ajcn.113.059600. Epub 2013 Sep 4.
citation: Dodt RC, Joventino ES, Aquino PS, Almeida PC, Ximenes LB. An experimental study of an educational intervention to promote maternal self-efficacy in breastfeeding. Rev Lat Am Enfermagem. 2015 Jul-Aug;23(4):725-32. doi: 10.1590/0104-1169.0295.2609.