PREterM FOrmula Or Donor Breast Milk for Premature Babies (PREMFOOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01686477
First received: August 7, 2012
Last updated: September 5, 2014
Last verified: August 2013
  Purpose

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.

In order to address this crucial question, central to preterm newborn care, a multicentre 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.

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.


Condition Intervention
Adiposity
Insulin Resistance
Metabolomic Profile
microRNA Profile
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Total Body Adiposity [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
    As measured by whole body Magnetic Resonance Imaging (MRI). 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).


Secondary Outcome Measures:
  • Feasibility data [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    1. test the acceptability of the trial design with parents and clinicians
    2. test that recruitment to target is achievable, estimate consent and dropout rates
    3. estimate the trial requirement for HDM from NHS Human Milk Banks
    4. test that clinical outcome data can be retrieved from operational NHS electronic records, thus minimising the burden of data capture and facilitating the use of linked NHS records to achieve long-term follow-up at low cost.


Other Outcome Measures:
  • Total Body adiposity [ Time Frame: Term (37-42 weeks corrected gestational age) and 6 weeks corrected ] [ Designated as safety issue: No ]
  • Regional adiposity, as measured by whole body MRI [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Non adipose tissue, as measured by whole body MRI [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Anthropometry (weight, length, and head circumference) [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Intra-hepatocellular Lipid, measured by magnetic resonance spectroscopy [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Stool and urine metabolomic profile, measured using high throughput nuclear magnetic resonance (NMR) spectroscopy [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Blood Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
    Calculated from fasting pre feed blood glucose and insulin

  • Blood microRNA profile using high throughput sequencing techniques [ Time Frame: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks) ] [ Designated as safety issue: No ]
  • Regional adiposity, as measured by whole body MRI [ Time Frame: Term plus 6 weeks corrected age ] [ Designated as safety issue: No ]
  • Non adipose tissue, as measured by whole body MRI [ Time Frame: Term plus 6 weeks corrected age ] [ Designated as safety issue: No ]
  • Anthropometry (weight, length, and head circumference) [ Time Frame: Term plus 6 weeks corrected age ] [ Designated as safety issue: No ]
  • Intra hepato-cellular Lipid, as measured by magnetic resonance spectroscopy [ Time Frame: Term plus 6 weeks corrected age ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Term plus 6 weeks corrected ] [ Designated as safety issue: No ]
  • Stool and urine metabolomic profile, measured using high throughput nuclear magnetic resonance (NMR) spectroscopy [ Time Frame: Term plus 6 weeks corrected ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unfortified Human Donor Milk
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
Active Comparator: Fortified 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
Active Comparator: Preterm Formula
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

  Eligibility

Ages Eligible for Study:   25 Weeks to 31 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686477

Contacts
Contact: Luke W Mills, MBChB 0208 237 5101 l.mills@imperial.ac.uk
Contact: Neena Modi, MBChB : 0208 237 5102 n.modi@imperial.ac.uk

Locations
United Kingdom
Chelsea and Westminster Hospital Neonatal Unit Recruiting
London, United Kingdom, SW10 9NH
Contact: Mary Tourette       research.development@chelwest.nhs.uk   
Principal Investigator: Luke W Mills, MBChB         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Neena Modi, MBChB Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01686477     History of Changes
Other Study ID Numbers: CRO2006
Study First Received: August 7, 2012
Last Updated: September 5, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014