Completed

PREMFOODPreterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk

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What is being tested

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

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

Other
Who is being recruted

Body Weight+9

+ Hyperinsulinism

+ Metabolic Diseases

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorImperial College London
Last updated: April 26, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: April 2, 2013

Actual date on which the first participant was enrolled.

Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers giving birth preterm are able to provide less than half their baby's milk requirements. Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical outcomes is unknown. Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF, is very variable in composition. Clinicians who use HDM do so primarily in the hope that despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a serious, devastating inflammatory disease characterised by bowel death and multisystem failure. These are two of the most feared conditions in newborn medicine as described above. Landmark nutritional trials in the early 1980's suggest positive effects of human milk on insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it benefits growth, including brain growth, and improves neurodevelopmental outcome. Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM, unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age with a sample size of 22 in each group. The trial is designed to reflect current preterm feeding practice. The trial will take place in neonatal units in London and parent consent obtained within 48hr of birth. Permission will be sought for long term follow up, initially from parents (later from children themselves). Outcomes will be body composition using magnetic resonance imaging and other imaging techniques. This pilot study will specifically assess feasibility by testing 1) provision of HDM by Human Milk Banks in London 2) acceptability to parents and clinicians using feedback on trial design 3) recruitment to target and 4) retrieval of clinical data for all recruited babies form the National Neonatal Database.

Principal SponsorImperial College London
Last updated: April 26, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

103 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperinsulinismMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightInsulin ResistanceObesity

Criteria

2 inclusion criteria required to participate
Preterm infants born between 25+0 to 31+6 weeks gestational age

Written informed consent from parents

2 exclusion criteria prevent from participating
Inability to randomise infant within 48 hours

Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Chelsea and Westminster Hospital Neonatal Unit

London, United KingdomOpen Chelsea and Westminster Hospital Neonatal Unit in Google Maps
CompletedOne Study Center