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

NCT06025864 | Unknown DMC

• 1 other identifier: 5947.21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Congenital Heart Disease

Keywords

breast milk; congenital heart desease; nutritional status; 6 months; call center

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Compare the time of breastfeeding

  Up to 6 months

• Breastfeeding self-efficacy before and during the intervention

  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

  Up to 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Breastfeeding OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants diagnosed with congenital heart disease,
• The parents must have a cell phone enabled to receive video calls.

You may not qualify if:

• Mothers carriers of the human immunodeficiency virus (HIV),
• Mothers users of medications without medical indication to initiate or maintain breastfeeding.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Juliana Caprini

Caxias do Sul, Rio Grande do Sul, 95080560, Brazil

RECRUITING

Related 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.

  PMID: 24004897 RESULT

• 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.

  PMID: 26444176 RESULT

MeSH Terms

Conditions

Breast Feeding; Heart Defects, Congenital

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Fernanda Lucchese-Lobato, PHD

  Instituto de Cardiologia de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Caprini, Esp

CONTACT

(54)992044907; juli_caprini@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: July 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: February 20, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)