Preterm milk Fortification in Neonates

Not Applicable

Completed

• Conditions: Preterm gut inflammation and other outcomes of prematurity (growth, length of hospital stay); Neonatal Diseases; Disorders 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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Study Completion: 2023-04-28
• Last Update Posted: 4 March 2024

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