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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Breastfeeding
• Intervention / Treatment: Other: Breastfeeding

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana Caprini, Esp; Phone Number: (54)992044907; Email: juli_caprini@yahoo.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Caxias do Sul, Rio Grande Do Sul, Brazil, 95080560
      • Recruiting
      • Juliana Caprini
      • Contact: Juliana Caprini, Esp; Phone Number: (54)992044907; Email: juli_caprini@yahoo.com
      • Principal Investigator: Fernanda Lucchese-Lobato, PHD
      • Sub-Investigator: Juliana Caprini, Esp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.	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.
No Intervention: Control Group; All mothers were followed up for 6 months and received a breastfeeding support booklet virtually, through a cell phone application. The booklet provides basic information about breastfeeding and possible complications. The recruited mothers also received a notebook to record the date, duration, volume and frequency of breastfeeding and/or milk collections, and the use of alternative routes such as a bottle, cup or enteral nutrition. At the initial visit, all mothers were given a standard measuring cup to measure the volume of milk used up in the household each day. In addition, all mothers received a call 7 days after delivery to apply the Portuguese version of the Breastfeeding Self-Efficacy Survey - Short Form: BSES-SF. This questionnaire was reapplied after 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the time of breastfeeding	Compare the time of offering the breast between the control group and the intervention group	Up to 6 months
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
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

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Investigators: Principal Investigator: Fernanda Lucchese-Lobato, PHD, Instituto de Cardiologia de Porto Alegre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): February 20, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: nutritional status; breast milk; call center; congenital heart desease; 6 months
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 5947.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No