Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- BREASTFEEDING RATES
研究概览
简要总结
This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding problems. It is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. The intervention lasts 6 months.
详细描述
Will be included moderately premature infants to the Neonatal Unit of the Hospital Clínic who achieve with the inclusion criteria of the study. The sample calculation includes 162 subjects to increase breastfeeding rates to 70% at discharge, 50% at 3 months and 40% at 6 months of the babies. Mothers who wish to exclusively breastfeed up to 6 months and sign the informed consent, will be randomized into the experimental group or control group. The control group will receive usual care and the experimental group will receive 1 pre-discharge face-to-face session, 8 home care sessions up to 4 months and 3 telephone follow-up sessions up to 6 months of baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate premature
- •Late premature babies
- •Admitted to the NICU of Hospital Clínic
- •Single pregnancy
- •Families residing in the Barcelona Metropolitan Area (AMB)
- •Families with a good mental health
- •Families with a desire for Exclusive Breastfeeding up to 6 months
排除标准
- •Maternal diseases that contraindicate breastfeeding
- •Mothers with a history of breast surgery
- •Mothers with a history of severe hypogalactia
- •Premature babies with severe complications
- •Premature babies diagnosed with severe CIR
结局指标
主要结局
BREASTFEEDING RATES
时间窗: 15 days postpartum, at 3 months and at 6 months postpartum
Exclusive Breastfeeding or Parcial Breastfeeding
次要结局
- PREMATURE HEIGHT(15 days postpartum, at 3 and 6 months postpartum)
- PREMATURE GROWTH(15 days postpartum, at 3 and 6 months postpartum)
- PREMATURE CRANIAL PERIMETER(15 days postpartum, at 3 and 6 months postpartum)
- PUNTUATION IN DEVELOPMENT WITH ASQ-3(At 6 months postpartum)
- MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)(15 days postpartum and at 6 months postpartum)
研究者
Mireia Pascual Tutusaus
Principal Investigator
University of Barcelona