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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025864
• Other study ID #: 5947.21
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: August 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Juliana Caprini, Esp
• Phone: (54)992044907
• Email: juli_caprini[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Juliana Caprini	Caxias do Sul	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk supply rate during the baby's 6-month period	Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.	Up to 6 months
Secondary	Compare the time of breastfeeding	Compare the time of offering the breast between the control group and the intervention group	Up to 6 months
Secondary	Breastfeeding self-efficacy before and during the intervention	The 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.	Up to 6 months
Secondary	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	Assess 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.	Up to 6 months