Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart Disease
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| ClinicalTrials.gov Identifier: NCT06025864 |
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Recruitment Status :
Recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breastfeeding Congenital Heart Disease | Other: Breastfeeding | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Multicenter Randomized Clinical Trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 1, 2022 |
| Estimated Primary Completion Date : | December 20, 2023 |
| Estimated Study Completion Date : | February 20, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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. |
- Breast milk supply rate during the baby's 6-month period [ Time Frame: Up to 6 months ]Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.
- Compare the time of breastfeeding [ Time Frame: Up to 6 months ]Compare the time of offering the breast between the control group and the intervention group
- Breastfeeding self-efficacy before and during the intervention [ Time Frame: Up to 6 months ]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 [ Time Frame: Up to 6 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Day to 3 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025864
| Contact: Juliana Caprini, Esp | (54)992044907 | juli_caprini@yahoo.com |
| Brazil | |
| Juliana Caprini | Recruiting |
| Caxias do Sul, Rio Grande Do Sul, Brazil, 95080560 | |
| Contact: Juliana Caprini, Esp (54)992044907 juli_caprini@yahoo.com | |
| Principal Investigator: Fernanda Lucchese-Lobato, PHD | |
| Sub-Investigator: Juliana Caprini, Esp | |
| Principal Investigator: | Fernanda Lucchese-Lobato, PHD | Instituto de Cardiologia de Porto Alegre |
| Responsible Party: | Fernanda Lucchese, Principal Investigator, Instituto de Cardiologia do Rio Grande do Sul |
| ClinicalTrials.gov Identifier: | NCT06025864 |
| Other Study ID Numbers: |
5947.21 |
| First Posted: | September 6, 2023 Key Record Dates |
| Last Update Posted: | September 6, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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breast milk congenital heart desease nutritional status 6 months call center |
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Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |