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

Primary Purpose

Breastfeeding, Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Breastfeeding
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breastfeeding focused on measuring breast milk, congenital heart desease, nutritional status, 6 months, call center

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Juliana CapriniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare the time of breastfeeding
Compare the time of offering the breast between the control group and the intervention group
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.
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.

Full Information

First Posted
August 21, 2023
Last Updated
August 30, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT06025864
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Congenital Heart Disease
Keywords
breast milk, congenital heart desease, nutritional status, 6 months, call center

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter Randomized Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Support for breastfeeding and depletion of breast milk throughout the 6 months. Free and professional support through monthly consultations and videos on the subject.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breastfeeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breast milk supply rate during the baby's 6-month period
Description
Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Compare the time of breastfeeding
Description
Compare the time of offering the breast between the control group and the intervention group
Time Frame
Up to 6 months
Title
Breastfeeding self-efficacy before and during the intervention
Description
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.
Time Frame
Up to 6 months
Title
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
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Caprini, Esp
Phone
(54)992044907
Email
juli_caprini@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Lucchese-Lobato, PHD
Organizational Affiliation
Instituto de Cardiologia de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juliana Caprini
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95080560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Caprini, Esp
Phone
(54)992044907
Email
juli_caprini@yahoo.com
First Name & Middle Initial & Last Name & Degree
Fernanda Lucchese-Lobato, PHD
First Name & Middle Initial & Last Name & Degree
Juliana Caprini, Esp

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24004897
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.
Results Reference
result
PubMed Identifier
26444176
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.
Results Reference
result

Learn more about this trial

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

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