ISRCTN15469594
Completed
N/A
Feeding Late and Moderately Preterm Infants Nutrition and Growth Outcomes (FLAMINGO)
ewcastle Hospitals NHS Foundation Trust0 sites182 target enrollmentMay 14, 2018
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ate and moderately preterm infants
- Sponsor
- ewcastle Hospitals NHS Foundation Trust
- Enrollment
- 182
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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