N/A
N=103
PREterM FOrmula Or Donor Breast Milk for Premature Babies
Adiposity · Insulin Resistance · Metabolomic Profile · microRNA Profile
Bottom Line
View on ClinicalTrials.gov: NCT01686477 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Total Body Adiposity — 0.893; 0.863; 0.809 Litres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Body Adiposity |
0.893; 0.863; 0.809 | — |
| SECONDARY Consent Rate for Feeding Intervention (Opt Out Approach) |
103 | — |
| SECONDARY Parental Withdrawal From Feed Intervention |
6 | — |
| SECONDARY Parental Withdrawal Rate From Feed Intervention by Arm |
0; 6; 0 | — |
| SECONDARY Clinician Refusal to Randomise |
— | — |
| SECONDARY Safety Criteria Threshold |
1; 0; 1 | — |
| SECONDARY Weight at Term |
3295; 3185; 3153 | — |
| SECONDARY Length at Term |
50.0; 49.5; 49.6 | — |
| SECONDARY Head Circumference at Term |
35.9; 35.0; 35.4 | — |
| SECONDARY Regional Adiposity, as Measured by Whole Body MRI, at Term. |
0.043; 0.044; 0.040 | — |
| SECONDARY Non Adipose Tissue, as Measured by Whole Body MRI, at Term |
2511.79; 2385.74; 2424.70 | — |
| SECONDARY Weight at Term Plus 6 Weeks |
4564; 4594; 4590 | — |
| SECONDARY Length at Term Plus 6 Weeks |
55.70; 55.86; 55.98 | — |
| SECONDARY Head Circumference at Term Plus 6 Weeks |
38.76; 37.89; 38.91 | — |
| SECONDARY Total Body Adiposity at Term Plus 6 Weeks |
1.355; 1.474; 1.353 | — |
| SECONDARY Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks |
0.064; 0.061; 0.062 | — |
| SECONDARY Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks |
3263.98; 3208.10; 3364.38 | — |
| SECONDARY Blood Quantitative Insulin Sensitivity Check Index (QUICKI) |
0.46; 0.42; 0.45 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Preterm infants born between 25+0 to 31+6 weeks gestational age
- Written informed consent from parents
Exclusion Criteria
- Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
- Inability to randomise infant within 48 hours
Data sourced from ClinicalTrials.gov (NCT01686477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.