Optimising nutrition to improve growth and reduce neurodisabilities in neonates at risk of neurological impairment: a randomised interventional treatment trial

Oxford University Hospital Trust (UK)0 个研究点目标入组 60 人开始时间: 2012年11月9日最近更新: 2019年2月11日

试验速览

•Inclusion will depend on the presence of one or more of the following criteria:
•Birth =30+6 weeks gestation:
•1. Small for gestational age - weight <9th centile
•2. Grade II, III or IV Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH)
•Birth 31-40+28 weeks gestation:
•1. Grade II, III or IV Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH)
•2. Magnetic resonance imaging (MRI) scan abnormalities in posterior limb of the internal capsule (PLIC), Basal Ganglia or Thalami, White Matter and Cortex
•Encephalopathy supported by either:
•1. Moderately abnormal amplitude-integrated electroencephalography (aEEG)
•2. Sarnat Grade II or III

•Exclusion will depend on the presence of one or more of the following criteria:
•Birth =30+6 weeks gestation:
•1. Weight >9th centile
•2. Grade I Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH)
•3. Profound hearing loss such that Bayley Assessment cannot be completed
•4. Progressive neurological degenerative conditions
•5. Gastrointestinal disease which significantly impairs absorption
•6. Multiple congenital abnormalities or syndromic associations
•7. Parents considered by clinicians to be unable to follow the study protocoL
•Birth 31-40+28 weeks gestation:
•1. Grade I Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH)
•2. Profound hearing loss such that Bayley Assessment cannot be completed
•3. Progressive neurological degenerative conditions
•4. Gastrointestinal disease which significantly impairs absorption
•5. Multiple congenital abnormalities or syndromic associations
•6. Parents considered by clinicians to be unable to follow the study protocol

发起方

Oxford University Hospital Trust (UK)