Effect of Developmental Care on Very Low Birth Weight Infants: a Stepped-wedge Cluster Randomised Trial
概览
- 阶段
- 不适用
- 干预措施
- developmental care
- 疾病 / 适应症
- Intervention
- 发起方
- Children's Hospital of Fudan University
- 入组人数
- 1600
- 试验地点
- 2
- 主要终点
- Length of hospital stay
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:
- Does developmental care shorten the length of hospital stay in the very low birth weight infants?
- Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.
详细描述
Developmental care in the NICU focuses on creating a nurturing environment that supports the physical, emotional, and developmental needs of premature infants. This approach includes strategies like minimizing unnecessary noise and light, ensuring appropriate positioning and handling of infants, promoting skin-to-skin contact, and facilitating parental involvement in care. The clinical trial investigates the effectiveness of developmental care in very low birth weight (VLBW) infants. The primary objectives are to determine whether developmental care can (1) reduce the length of hospital stay and (2) enhance the opportunity for family-centered care in these infants. The study employs a 36-month stepped-wedge cluster-randomised trial design, involving 40 Neonatal Intensive Care Units (NICUs). In this trial, all NICUs will eventually receive the intervention, but the order in which they start implementing the developmental care bundle will be randomized. This approach allows each NICU to serve as its own control, comparing outcomes before and after the intervention. Data collection will occur at multiple time points before and after the implementation of the developmental care bundle, enabling a comprehensive analysis of its impact. By tailoring interventions to each NICU's specific context and needs, the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families.
研究者
入排标准
入选标准
- •Birth weights less than 1500 g
- •Admitted or transported to a level III NICU within 24h of birth
排除标准
- •Severe congenital malformations
- •various chromosomal disorders
- •genetic metabolic diseases,
- •severe neurological disorders
研究组 & 干预措施
Developmental care
In stage 1, participant in this arm will receive the developmental care
干预措施: developmental care
Usual care
Participant in this arm will receive the usual care
结局指标
主要结局
Length of hospital stay
时间窗: From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Length of hospital stay (in days)
次要结局
- Skin to skin care duration(From the day admitted into the NICU until day on discharge, generally assessed up to 1 year)