Support Protocol for Face-to-face and Teleservice Breastfeeding for Puerperal Women and Mothers of Babies With Congenital Heart Disease: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Breast milk supply rate during the baby's 6-month period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants diagnosed with congenital heart disease,
- •The parents must have a cell phone enabled to receive video calls.
排除标准
- •Mothers carriers of the human immunodeficiency virus (HIV),
- •Mothers users of medications without medical indication to initiate or maintain breastfeeding.
研究组 & 干预措施
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.
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.
干预措施: Breastfeeding (Other)
结局指标
主要结局
Breast milk supply rate during the baby's 6-month period
时间窗: Up to 6 months
Increase milk supply directly from the mother's breast or through pumps for use in alternative routes.
次要结局
- 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)
- Compare the time of breastfeeding(Up to 6 months)
- Breastfeeding self-efficacy before and during the intervention(Up to 6 months)
研究者
Fernanda Lucchese
Principal Investigator
Instituto de Cardiologia do Rio Grande do Sul