A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- All-cause Mortality
研究概览
简要总结
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates <2000g in a resource limited hospital setting.
详细描述
This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates <2000g and aged <24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at <24h of admission) or standard care with continuous KMC at >24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.
Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.
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 Hour 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New admission to study site during study period
- •Admission weight <2000g
- •Age 1 - 24h at start of screening
- •Alive at enrolment
- •Availability of study bed
- •Written informed consent from parent or caregiver
- •Parent or caregiver available and willing to provide intervention, if necessary
排除标准
- •Congenital malformation incompatible with life or needing immediate surgical correction
- •Severe jaundice needing immediate management
- •Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
- •Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
- •Completed triplet admission
- •Mother and/or neonate enrolled in another research study at time of hospital admission
研究组 & 干预措施
Early KMC
Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home
干预措施: Early Kangaroo Mother Care (Other)
Standard care
Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home
干预措施: Standard care (Other)
结局指标
主要结局
All-cause Mortality
时间窗: 28 days
All neonatal deaths within 28 postnatal days
次要结局
- Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae(At day 28 of age)
- Duration of Hospital Admission(Within 28 days of age or at latest follow-up)
- Number and Proportion of Participants With Hypothermia(At 24 hours after start of intervention/control procedures)
- Exclusive Breastfeeding(At time of hospital discharge, within study period, on average 2 weeks of age)
- Time to Death(28 days of age)
- Suspected Infection Between 3d to 28d of Age(Within 28 days of age)
- Cardio-respiratory Stability(At 24 hours after start of intervention/control procedures)
- Weight Gain(At 28 days of age)