Babies born with hypoxic ischaemic encephalopathy (where the brain did not receive enough oxygen around the time of birth) or babies born premature (born less than 28 weeks of gestation) Neonatal Diseases Hypoxic ischaemic encephalopathy of newborn
Conditions
Interventions
This trial aims to establish whether or not early life nutritional supplementation with a nutrient blend of long-chain polyunsaturated fatty acids (LCPUFAs), choline, uridine-5'-monophosphate (UMP), a
538 preterm and 472 infants born at or after 35 weeks of gestation with HIE cared for in neonatal units across the UK participate. A 9-month internal pilot phase incorporates “stop-go” criteria to eva
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Months to 3 Months
Inclusion criteria
Inclusion criteria: 1. Preterm stratum: Infants born less than 28 weeks of gestation, up to discharge home from neonatal unit (NNU) or step-down site, and no more than 3 months post-estimated date of delivery (EDD) 2. Hypoxic ischaemic encephalopathy (HIE) stratum: Infants born at 35 weeks of gestation or more, who have received therapeutic hypothermia for HIE, up to 40 weeks of gestation plus 28 days 3. Individual with parental responsibility able to give consent. In the event that the mother is unable to give consent, or does not have parental responsibility consent can be given by another person who has parental responsibility. Maternal consent for the purposes of maternal data collection will be sought as soon as practical 4. Parents able to comply with the protocol 5. Infants likely to tolerate full enteral feeds 6. Infant has a realistic prospect of survival beyond discharge
Exclusion criteria
Exclusion criteria: 1. Infants with middle cerebral artery infarcts 2. Infants with major congenital brain malformation, or genetic condition with abnormal brain development 3. Infants with galactosaemia 4. Infants receiving continuous enteral feeds, including jejunal feeds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive development measured using the non-verbal cognitive scale standardised score of the Parent Report of Children’s Abilities-Revised (PARCA-R) questionnaire at age 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary neurodevelopmental outcomes measured at 24 months of age post EDD: 1.1. Language Development Scale standardised score of the PARCA R questionnaire 1.2. Parent-reported emotional, conduct, peer problems, hyperactivity, prosocial and total score measured using the Strengths and Difficulties Questionnaire 1.3. Parent-reported motor skills measured using the fine and gross motor scales score of the Ages and Stages Questionnaire (ASQ-3) 2. Infant growth outcomes measured at 24 months of age post EDD: 2.1. Weight standard deviation score 2.2. Head circumference standard deviation score 2.3. Overweight or obese (BMI =85th percentile) 3. Clinical outcomes measured at discharge home from the neonatal unit: 3.1. Microbiologically confirmed late-onset invasive infection 3.2. Necrotising enterocolitis requiring surgery 3.3. Retinopathy of prematurity treated medically/surgically (preterm stratum only) 3.4. Chronic lung disease (preterm stratum only) 4. Safety, infant tolerability, adherence to and parental acceptability measured using: 4.1. Safety and adverse events until age 12 months plus 2 weeks after the end of the intervention period 4.2. Parent-reported infant tolerability of supplement (IGSQ) at discharge home from neonatal unit, 3, 6 and 12 months 4.3. Parent-reported adherence until age 12 months 4.4. Parent-reported acceptability of the supplement at 6 and 12 months 5. Maternal health-related quality of life measured using: 5.1. EuroQol EQ-5D-5L questionnaire at baseline, 6, 12, 18 and 24 months 5.2. Maternal quality-adjusted life years (QALYs) up to 24 months 6. Healthcare and social care resource use and costs, costs borne by families, and wider societal implications including family expenses and employment, measured using: 6.1. Health and social care resource use and costs and out-of-pocket costs incurred by families up to 24 months 6.2. Productivity costs and informal care up to 24 months 6.3. Cost per life-year without moderate/severe neurodevelopm | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Outcome results
None listed