We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686477
Recruitment Status : Unknown
Verified June 2019 by Imperial College London.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2012
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk
Study Start Date : August 2013
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Feasibility data [ Time Frame: 18 months ]
    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 National Health Service (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:
  1. Total Body adiposity [ Time Frame: Term (37-42 weeks corrected gestational age) and 6 weeks corrected ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
    Calculated from fasting pre feed blood glucose and insulin

  9. 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) ]
  10. Regional adiposity, as measured by whole body MRI [ Time Frame: Term plus 6 weeks corrected age ]
  11. Non adipose tissue, as measured by whole body MRI [ Time Frame: Term plus 6 weeks corrected age ]
  12. Anthropometry (weight, length, and head circumference) [ Time Frame: Term plus 6 weeks corrected age ]
  13. Intra hepato-cellular Lipid, as measured by magnetic resonance spectroscopy [ Time Frame: Term plus 6 weeks corrected age ]
  14. Blood pressure [ Time Frame: Term plus 6 weeks corrected ]
  15. Stool and urine metabolomic profile, measured using high throughput nuclear magnetic resonance (NMR) spectroscopy [ Time Frame: Term plus 6 weeks corrected ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686477


Locations
Layout table for location information
United Kingdom
Chelsea and Westminster Hospital Neonatal Unit
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Imperial College London
Investigators
Layout table for investigator information
Principal Investigator: Neena Modi, MBChB Imperial College London
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01686477    
Other Study ID Numbers: CRO2006
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases