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PREterM FOrmula Or Donor Breast Milk for Premature Babies

NCT01686477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2024-04-26

Study results available
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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.

Conditions

Interventions

OTHER

Unfortified Human donor Milk used to make up any shortfall in mother's own milk

OTHER

Fortified Human donor Milk used to make up any shortfall in mother's own milk

OTHER

Preterm Formula used when there is a shortfall in mother's own milk

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Neena Modi, MBChB · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-02
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686477 on ClinicalTrials.gov