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Clinical Trials/ISRCTN15469594
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)

Registry
who.int
Start Date
May 14, 2018
End Date
May 21, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
ewcastle Hospitals NHS Foundation Trust

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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