PREterM FOrmula Or Donor Breast Milk for Premature Babies

NCT01686477 | Completed Results

• 1 other identifier: CRO2006
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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

Adiposity; Insulin Resistance; Metabolomic Profile; microRNA Profile

Outcome Measures

Primary Outcomes (1)

• Total Body Adiposity

  As measured by whole body Magnetic Resonance Imaging (MRI). MR images were acquired using a rapid T1-weighted spin-echo sequence allowing whole body imaging. Images obtained give good contrast between adipose tissue and other tissues, and allows direct measurement of adipose compartment volumes, whole body adipose volume being the sum of these compartments. The time taken to reach term age equivalent will vary depending on the birth gestational age of the infant. The range will be 8-15 weeks (representing gestational birth age from 25-32 weeks).

  Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks)

Secondary Outcomes (17)

• Consent Rate for Feeding Intervention (Opt Out Approach)

  Up to the first 48hrs of life

• Parental Withdrawal From Feed Intervention

  From birth to 35 weeks post menstrual age

• Parental Withdrawal Rate From Feed Intervention by Arm

  From birth to 35 weeks post menstrual age

• Clinician Refusal to Randomise

  Up to the first 48hrs of life.

• Safety Criteria Threshold

  Birth to 35 weeks post menstrual age

Study Arms (3)

Unfortified Human Donor Milk

ACTIVE COMPARATOR

Used to make up any shortfall in mother's own milk

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

Fortified Human Donor Milk

ACTIVE COMPARATOR

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

Preterm Formula

ACTIVE COMPARATOR

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

Interventions

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

Unfortified Human Donor Milk

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

Fortified Human Donor Milk

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

Preterm Formula

Eligibility Criteria

• Age: 25 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born between 25+0 to 31+6 weeks gestational age
• Written informed consent from parents

You may not qualify if:

• Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
• Inability to randomise infant within 48 hours

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Chelsea and Westminster Hospital Neonatal Unit

London, SW10 9NH, United Kingdom

Location

Related Publications (1)

• Quigley M, Embleton ND, Meader N, McGuire W. Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024 Sep 6;9(9):CD002971. doi: 10.1002/14651858.CD002971.pub6.

  PMID: 39239939 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Results Point of Contact

• Title: Luke Mills
• Organization: ImperialC

l.mills@imperial.ac.uk

+447989748017

Study Officials

• Neena Modi, MBChB

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: September 18, 2012
• Study Start: April 2, 2013
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2023-10

Locations

GB (1)