Feeding late and moderately preterm infants

Not Applicable

Completed

Conditions: ate and moderately preterm infants
Neonatal Diseases
Other preterm infants

Registration Number: ISRCTN15469594

Lead Sponsor: ewcastle Hospitals NHS Foundation Trust

Brief Summary: 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33763438/ (added 26/03/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36183005/ (added 10/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 182

Inclusion Criteria

1. Healthy moderate to late preterm infants (gestational age = 32 and = 36 6/7 weeks)
2. Age at inclusion = term equivalent age
3. Birth weight between 1.25-2.5 kg
4. Infants who are predominantly formula fed (max. 1 breastfeeding per day) using a standard term infant formula
5. Written informed consent from parent(s) and/or legal guardian, aged = 18 years, to be enrolled into a randomised trial

Exclusion Criteria

1. Any gastrointestinal, congenital or other problem likely to affect growth and nutrition, or requiring use of specialised milk formula or other diet e.g. due to confirmed allergy; or where the attending medical team feel that trial participation is inappropriate for any other medical condition
2. Ongoing child protection procedures or maternal drug misuse requiring social services involvement
3. Family circumstances where follow-up not likely to be possible e.g. family travel abroad for prolonged periods, or where it appears likely that the family will be unable to comply with the necessary research visits
4. Participation in another interventional study that may potentially confound or interact with this study
5. Family unable to understand English

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily weight gain from randomisation until 3 months corrected age. Weight measured using standard weighing scales at baseline, discharge, term equivalent age (TEA), 3,6,12 and 24 months corrected age

Secondary Outcome Measures