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Clinical Trials/ISRCTN16799022
ISRCTN16799022
Completed
未知

Interactions between the diet and gut microbes and metabolism in preterm infants (INDIGO study)

The Newcastle Upon Tyne Hospitals NHS Foundation Trust0 sites128 target enrollmentJuly 24, 2017
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ConditionsDigestive health of preterm infantsNeonatal Diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Digestive health of preterm infants
Sponsor
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Enrollment
128
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36857051/ (added 02/03/2023)

Registry
who.int
Start Date
July 24, 2017
End Date
February 28, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Current inclusion criteria as of 11/03/2021:
  • •1\. Preterm infants born below 30 completed weeks of gestation (\<\=29 weeks and 6 days)
  • •2\. Written informed consent from parents
  • •3\. Has not received any milk other than MOM
  • •Previous inclusion criteria:
  • •1\. Preterm infants born below 29 completed weeks of gestation (\<\=28 weeks and 6 days)
  • •2\. Written informed consent from parents
  • •3\. Has not received any milk other than MOM

Exclusion Criteria

  • •1\. Major congenital or life threatening abnormalities
  • •2\. Inability to randomise within 48 hours of birth
  • •3\. Exposure to bovine milk product prior to randomisation
  • •4\. Likelihood of transfer to another hospital before 34 weeks postmenstrual age

Outcomes

Primary Outcomes

Not specified

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