nderstanding Creatine for Neurological Health in Babies
Not Applicable
Recruiting
- Conditions
- Preterm BirthNeurological - Other neurological disordersDiet and Nutrition - Other diet and nutrition disordersReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12618000871246
- Lead Sponsor
- Hudson Institute of Medical Research/Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1.Singleton babies
2.Provision of Signed and Dated Informed Consent from Parent/Guardian
3.Preterm infants of gestational post maternal age receiving care within the Neonatal Intensive Care Unit at CCDHB, or, healthy term infants at 39-40 weeks gestation from low risk pregnancies delivered at CCDHB.
Exclusion Criteria
1.Babies with major congenital, genetic or chromosomal abnormalities known to affect neurodevelopmental outcomes
2.Hypoxic ischaemic encephalopathy
3.Inborn (proven or suspected) errors of metabolism
4.Fetal growth restriction (birth weight <10th percentile on customised percentiles)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infant creatine levels (composite outcome of plasma, urinary and cerebral measures) at term corrected age. Plasma and urine creatine will be measured using LC-MS, and cerebral creatine measured from an MRI/MRS scan. [Term corrected age]
- Secondary Outcome Measures
Name Time Method Creatine content of diet (TPN, formula or breastmilk) received by infants during their stay in hospital, measured using LC-MS. [term corrected age. ];Neurological outcomes of infants up to 3 month of age. Composite measures of MRI scans, general movements assessment and the DAYC-2 developmental assessment tool. [Term corrected age and 3 months of term corrected age. ]