Breastfeeding Peer Counselling for Mothers of Preterm Neonates: a Stepped- Wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,774
- 试验地点
- 16
- 主要终点
- Breastfeeding continuation rates
研究概览
简要总结
Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants.
The use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. Several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants.
The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in Europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits.
The breastfeeding support program will include peer counselors under the supervision of lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. After a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital.
The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France, Switzerland and Belgium). Infants and mothers will be followed up from the time of hospitalization in the maternity and NICU up to 6 months after the discharge. The cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any infant born <35 weeks' gestation,
- •hospitalised in NICU before 24 hours old
- •and younger than 168 hours (7 days) old.
排除标准
- •infant with foetal malformation that is life-threatening
- •infant with medical contraindication for breastfeeding
- •parent(s)' non-consent to be involved in the study
- •mother with prolonged medical contraindication for breastfeeding
- •mother with psychiatric disorders making breastfeeding support impossible
- •if no communication is possible with the mother
- •if the level of communication with the mother does not allow breastfeeding support, with or without a third party
结局指标
主要结局
Breastfeeding continuation rates
时间窗: at corrected postnatal age of 2 months
Breastfeeding will be defined as the consumption of any mother's own milk. It will be classed as exclusive when all of the fed milk is the mother's own milk, or mixed when it will be completed by other milk and/or food.
次要结局
- Neurodevelopment rate by Brunet Lézine scale(at corrected postnatal age of 24 months)
- Rate of breastfeeding initiated(at 2 months of corrected age)
- Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)(at corrected postnatal age of 6 months)
- Feasibility of the breastfeeding support program(24 months)
- Breastfeeding rate(at 6 months of corrected age)
- Breastfeeding duration(at 6 months of corrected age)
- Disability rate(at corrected postnatal age of 24 months)
- Infant behaviours(at corrected postnatal age of 6 months)
- Depression by the Edinburgh Postnatal Depression Scale.(at corrected postnatal age of 6 months)
- Mother-Infant bonding(at corrected postnatal age of 6 months)
- Anxiety by the Hospital Anxiety and Depression Scale (HADS)(at corrected postnatal age of 6 months)
- Neonatal severe complications(at 36 weeks of corrected age)
- Death rates(at 36 weeks of corrected age)
- Costs effectiveness of breastfeeding(up to first two years of life)
- Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF(at corrected postnatal age of 6 months)
- cost consequence of breastfeeding(up to first two years of life)
- Acceptability of the breastfeeding support program(24 months)