AdiposityPREMFOODNCT01686477
PREterM FOrmula Or Donor Breast Milk for Premature Babies
A study testing 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 and Preterm Formula used when there is a shortfall in mother's own milk in people with Adiposity and Insulin Resistance, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 31 weeksHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Insulin Resistance, Metabolomic Profile
- 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 and Preterm Formula used when there is a shortfall in mother's own milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2013to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 31 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born between 25+0 to 31+6 weeks gestational age
- Written informed consent from parents
Who cannot join
- Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
- Inability to randomise infant within 48 hours
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital Neonatal Unit
London, SW10 9NH
About this study
Official title: Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk
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.
Read the 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.
- Conditions
- Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
- 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
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfortified Human donor Milk used to make up any shortfall in mother's own milkOther
Fortified Human donor Milk used to make up any shortfall in mother's own milkOther
Preterm Formula used when there is a shortfall in mother's own milkOther
| Study group | Role | What they receive |
|---|---|---|
| Unfortified Human Donor Milk | Active comparator | Used to make up any shortfall in mother's own milk Receives: 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 Receives: 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 Receives: Other: Preterm Formula used when there is a shortfall in mother's own milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Consent rate for feeding intervention of number of parents of eligible infants approached and study discussed with (opt out approach)
Measured: Up to the first 48hrs of life
Parental Withdrawal From Feed Intervention
Parental withdrawal rate from feed intervention
Measured: From birth to 35 weeks post menstrual age
Parental Withdrawal Rate From Feed Intervention by Arm
Parental withdrawal rate from feed intervention by feed intervention arm
Measured: From birth to 35 weeks post menstrual age
Clinician Refusal to Randomise
Attending clinician refusal to randomise eligible infant into feeding intervention
Measured: Up to the first 48hrs of life.
Safety Criteria Threshold
Number of infants who met the weight gain safety criteria. Safety criteria defined by slow growth were based on the UK Neonatal and Infant Close Monitoring growth chart 2009: if after two weeks of reaching a milk volume of 120ml/kg/d, the infant showed a 3 marked centile downward crossing (equating to approximately a 1.4-2.0 z-score change from birthweight) fortification or formula was commenced
Measured: Birth to 35 weeks post menstrual age
Weight at Term
Weight at term by feed intervention arm
Measured: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks)
Length at Term
Length at term by feed intervention arm
Measured: Term corrected age (as close as possible to due date)
Head Circumference at Term
Head circumference at term by feed intervention arm
Measured: Term corrected age (as close as possible to due date)
Regional Adiposity, as Measured by Whole Body MRI, at Term.
Internal Abdominal Adipose Tissue at Term reported here. 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. These adipose compartments are defined as superficial subcutaneous, deep subcutaneous, and internal. Each of these three compartments are further subdivided into abdominal and non-abdominal.
Measured: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks)
Non Adipose Tissue, as Measured by Whole Body MRI, at Term
Non adipose tissue, as measured by whole body Magnetic Resonance Imaging (MRI) at term. 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 tissue volume being the sum of these adipose compartment volumes. This volume may be converted to adipose tissue mass on the assumption that the density of adipose tissue is 0.9 g/cm³. Non adipose tissue mass reported here is weight (g) minus whole body adipose mass (g)
Measured: Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks)
Weight at Term Plus 6 Weeks
Weight at Term plus 6 weeks by feed intervention arm
Measured: Term plus 6 weeks corrected age
Length at Term Plus 6 Weeks
Length at Term plus 6 weeks by feed intervention group
Measured: Term plus 6 weeks
Head Circumference at Term Plus 6 Weeks
Head circumference at Term plus 6 weeks by feed intervention arm
Measured: Term plus 6 weeks
Total Body Adiposity at Term Plus 6 Weeks
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, total body adipose tissue volume being the sum of all these compartment volumes.
Measured: Term plus 6 weeks
Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks
Regional adiposity, as measured by whole body MRI at Term plus 6 weeks, Internal Abdominal Adipose Tissue reported here. 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. These adipose compartments are defined as superficial subcutaneous, deep subcutaneous, and internal. Each of these three compartments are further subdivided into abdominal and non-abdominal.
Measured: Term plus 6 weeks corrected age
Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks
Non adipose tissue, as measured by whole body MRI, at Term plus 6 weeks. 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 tissue volume being the sum of these adipose compartment volumes. This volume may be converted to adipose tissue mass on the assumption that the density of adipose tissue is 0.9 g/cm³. Non adipose tissue mass reported here is weight (g) minus whole body adipose mass (g)
Measured: Term plus 6 weeks corrected age
Blood Quantitative Insulin Sensitivity Check Index (QUICKI)
The quantitative insulin sensitivity check index (QUICKI) is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose:
1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)). This index correlates well with glucose clamp studies and is useful for measuring insulin sensitivity (IS), which is the inverse of insulin resistance (IR). The higher the value of QUICKI, the higher the measure of insulin sensitivity. Reference ranges for adults, and less so preterm newborns, have not been fully established; values of 0.3 in adults or below are typically associated with insulin resistance or diabetes. In a large cohort of 115 term, normoweight newborns at birth (Gesteiro E. Eur J Pediatr. 2009 Mar;168(3):281-8), mean (95% confidence interval) QUICKI was 0.45 (0.43-0.48)
Measured: Measured at 35 weeks Post Menstrual Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start2 Apr 2013
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neena Modi, MBChB, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686477
- Sponsor's protocol ID
- CRO2006
- Acronym
- PREMFOOD
- Status last verified
- Oct 2023
- First submitted
- 7 Aug 2012
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 39239939
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk
- ClinicalTrials.gov ID
- NCT01686477
- Acronym / sponsor ID
- PREMFOOD / CRO2006
- Conditions
- Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Apr 2013 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unfortified Human Donor Milk | Active comparator | Other: Unfortified Human donor Milk used to make up any shortfall in mother's own milkUsed to make up any shortfall in mother's own milk |
| Fortified Human Donor Milk | Active comparator | Other: Fortified Human donor Milk used to make up any shortfall in mother's own milkUsed to make up any shortfall in mother's own milk |
| Preterm Formula | Active comparator | Other: Preterm Formula used when there is a shortfall in mother's own milkUsed to make up any shortfall in mother's own milk |
Who may qualify
- Ages
- 25 to 31 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants born between 25+0 to 31+6 weeks gestational age
- Written informed consent from parents
Key exclusion criteria (2 listed)
- Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
- Inability to randomise infant within 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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). 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).
17 secondary outcomes
Consent Rate for Feeding Intervention (Opt Out Approach)
Time frame: Up to the first 48hrs of life
Parental Withdrawal From Feed Intervention
Time frame: From birth to 35 weeks post menstrual age
Parental Withdrawal Rate From Feed Intervention by Arm
Time frame: From birth to 35 weeks post menstrual age
Clinician Refusal to Randomise
Time frame: Up to the first 48hrs of life.
Safety Criteria Threshold
Time frame: Birth to 35 weeks post menstrual age
Weight at Term
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)
Length at Term
Time frame: Term corrected age (as close as possible to due date)
Head Circumference at Term
Time frame: Term corrected age (as close as possible to due date)
Regional Adiposity, as Measured by Whole Body MRI, at Term.
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)
Non Adipose Tissue, as Measured by Whole Body MRI, at Term
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)
Weight at Term Plus 6 Weeks
Time frame: Term plus 6 weeks corrected age
Length at Term Plus 6 Weeks
Time frame: Term plus 6 weeks
Head Circumference at Term Plus 6 Weeks
Time frame: Term plus 6 weeks
Total Body Adiposity at Term Plus 6 Weeks
Time frame: Term plus 6 weeks
Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks
Time frame: Term plus 6 weeks corrected age
Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks
Time frame: Term plus 6 weeks corrected age
Blood Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: Measured at 35 weeks Post Menstrual Age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39239939Quigley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Modi, MBChB principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Preterm Formula used when there is a shortfall in mother's own milk in people with Adiposity and Insulin Resistance, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.