Preterm milk Fortification in Neonates
Not Applicable
Completed
- Conditions
- Preterm gut inflammation and other outcomes of prematurity (growth, length of hospital stay)Neonatal DiseasesDisorders related to short gestation and low birth weight
- Registration Number
- ISRCTN22484792
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Born at <32 weeks gestation
2. Never received cow milk-based diet (formula or fortifier) and having established full milk feeds
Exclusion Criteria
1. Previous necrotising enterocolitis or gut surgery or malformation
2. Previous receipt of cow milk based diet (formula or fortifier)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Faecal calprotectin measured from stool samples collected at baseline and 1 and 3 weeks after the intervention (until 36 weeks gestation, or when a fortifier is no longer required, whichever is earlier)
- Secondary Outcome Measures
Name Time Method 1. Faecal sIgA, cytokine panel, and bacterial taxa (by 16srRNA) measured from stool samples collected at baseline and 1 and 3 weeks after intervention<br>2. Infant health measured using records of growth, morbidities associated with preterm birth, length of hospital stay, and biochemical results between baseline until discharge from the neonatal unit