ACTRN12618000893202已完成未知
'Neonatal Encephalopathy Brain Outcomes (NEBO): Biomarkers in term born infants to improve accurate and earlier prediction of Cerebral Palsy
Prof Roslyn Boyd0 个研究点目标入组 64 人开始时间: 2018年5月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（—）
- 性别
- All
入选标准
- •(a) All babies who enter the Paean Trial, are eligible for the NEBO follow-up trial.
- •(b) Moderate to severe encephalopathy in the first 7 days after term delivery (greater than 35 plus weeks PMA) using the modified Sarnat classification;
- •(c) Male or female infants born at 35 plus 0 weeks gestation with HIE (perinatal depression).
- •(d) One or more of the following indications of perinatal depression:
- •Apgar of 5 at 10 minutes after birth OR
- •receiving ongoing resuscitation e.g. assisted ventilation (positive pressure ventilation or CPAP) or chest compressions at 10 minutes after birth OR
- •on cord blood or arterial or venous blood obtained at less than 60 minutes after birth,
- •pH less than 7.00 OR
- •base deficit of 12.0 mmol/L.
- •e) Moderate to severe encephalopathy, defined between one and six hours after birth by one or both of the following:
- •3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy;
- •2 out of 6 modified Sarnat criteria between one and six hours after birth, plus seizure(s) requiring anticonvulsant treatment (diagnosed either clinically or using EEG monitoring) at any time of study entry;
- •f) Hypothermia treatment initiated by 6 hours of age; i.e. controlled whole-body cooling planned to continue for 72 hours, to a target temperature (adjusted manually or with a device) and subsequent controlled re-warming
- •g) Informed consent;
- •h) Ability to receive 3T MRI at 1-10 days post-delivery (day 5-7 optimal) at 35+ weeks PMA (no metal inserts; i.e. no VP shunts)
- •In ADDITION the following babies not entered into the PAEAN intervention trial would be eligible for the NEBO observational trial:
- •i.Babies cooled too late
- •ii.Postnatal arrest with subsequent HIE
- •iii.Parents not approached (e.g. mother in ICU/too ill on 1st day)
- •iv.Babies whose parents declined PAEAN (not happy about an intervention trial but would agree to an observational study).
- •v.Babies who met all other criteria for PAEAN but had a contraindication to cooling – e.g. uncontrolled pulmonary hypertension or coagulopathy/bleeding – so didn’t get cooled.
- •Healthy term reference group:
- •a) born between 35 and 42 weeks gestation following an uncomplicated pregnancy and delivery,
- •b) have a birth weight above the 10th percentile
- •c) not admitted to neonatal intensive or special care units following their birth.
排除标准
- •(a)Unable to return for follow-up;
- •(b)Children with major congenital anomalies
- •(c)Where cessation of life support is under active discussion
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