Preterm gut inflammation and other outcomes of prematurity (growth, length of hospital stay) Neonatal Diseases Disorders related to short gestation and low birth weight
Conditions
Interventions
Babies born at <32 weeks gestation or <1500 g birthweight will be randomised using Sealed envelope (a commercial randomisation company) to one of two groups to receive:
1. Standard cows milk-based for
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Previous necrotising enterocolitis or gut surgery or malformation 2. Previous receipt of cow milk based diet (formula or fortifier)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Faecal sIgA, cytokine panel, and bacterial taxa (by 16srRNA) measured from stool samples collected at baseline and 1 and 3 weeks after intervention 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 | — |
Countries
England, United Kingdom
Outcome results
None listed