At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk
In Brief
A clinical study evaluating Unfortified Human donor Milk used to make up any shortfall in mother's own milk, Fortified Human donor Milk used to make up any shortfall in mother's own milk, and 1 other intervention for Adiposity and 3 related conditions. Completed, enrolled 103 participants across 1 site.
Detailed Summary
In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis and bloodstream infection, and establish cohorts large enough to address long-term metabolic (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental outcomes. This pilot trial will evaluate the practicability and feasibility of such a large multicentre UK randomised controlled trial. In addition to evaluating feasibility and to ensure maximal use of resources allocated, this study will also assess outcomes that are indicative of long term metabolic health.