Therapeutic Hypothermia for Perinatal Asphyxial Encephalopathy in a Low Resource Hospital Setting in Equatorial Africa: a Randomised Controlled Trial

niversity College London0 个研究点目标入组 36 人开始时间: 2010年6月28日最近更新: 2020年3月3日

试验速览

•Study infants will be near term or full term infants with:
•1. Need for resuscitation with assisted bag and mask ventilation after birth and/or an Apgar score of <6 at 5 minutes (10 minutes
•if available)
•2. Abnormal neurological assessment between 30 mins and 3 hrs of age
•An abnormal neurological examination at 30 mins will be defined as a score >5 on the standardised examination described by
•Thompson et al (Thompson et al., 1997).

•1. <35 weeks gestation or birthweight < 2000g
•2. Onset of regular breathing delayed > 20 mins or those who remain apnoeic and cyanotic
•3. Absent cardiac output > 10 mins
•4. > 3 hrs of age at study entry
•5. Major malformations
•6. Symptomatic infection
•7. Metabolic disease suspected at time of randomisation
•8. Families who live >20 km radius of Mulago Hospital
•9. Out born infants
•10. Those parents who do not speak or understand either English or Luganda or any parent who does not understand the study.

发起方

niversity College London