Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 804
- 试验地点
- 2
- 主要终点
- Death to discharge or at six months corrected gestational age
研究概览
简要总结
Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?
详细描述
Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.
Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.
Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support.
排除标准
- •Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele)
- •Infants born with blistering skin conditions that preclude the use of occlusive wrap
结局指标
主要结局
Death to discharge or at six months corrected gestational age
时间窗: discharge or six months corrected gestational age
次要结局
- 1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)(upon arrival in NICU)
- 4. Death and neurosensory disability measured at 18 months corrected gestational age(18 months corrected gestational age)
- acidosis, hypotension, hypoglycaemia, seizures(first 12 hours of life)
- PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP(discharge from hospital or 6 months corrected gestational age)
研究者
Maureen Reilly
RRT
Sunnybrook Health Sciences Centre