Developmental outcomes of long-term feed supplementation in newborn babies

Not Applicable

• Conditions: 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

• Registration Number: ISRCTN62323236
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-16
• Last Update Posted: 28 November 2023
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1143

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified