Preterm Formula or Donor Breast Milk to Make up Any Shortfall in Mother's Own Milk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adiposity
- Sponsor
- Imperial College London
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Total Body Adiposity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Non Adipose Tissue, as Measured by Whole Body MRI, at Term(Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks))
- Consent Rate for Feeding Intervention (Opt Out Approach)(Up to the first 48hrs of life)
- Parental Withdrawal From Feed Intervention(From birth to 35 weeks post menstrual age)
- Weight at Term(Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks))
- Regional Adiposity, as Measured by Whole Body MRI, at Term.(Measured as close as possible to the baby's due date, at an average age of 10 weeks (range 8 to 15 weeks))
- Head Circumference at Term Plus 6 Weeks(Term plus 6 weeks)
- Parental Withdrawal Rate From Feed Intervention by Arm(From birth to 35 weeks post menstrual age)
- Safety Criteria Threshold(Birth to 35 weeks post menstrual age)
- Head Circumference at Term(Term corrected age (as close as possible to due date))
- Weight at Term Plus 6 Weeks(Term plus 6 weeks corrected age)
- Length at Term Plus 6 Weeks(Term plus 6 weeks)
- Total Body Adiposity at Term Plus 6 Weeks(Term plus 6 weeks)
- Clinician Refusal to Randomise(Up to the first 48hrs of life.)
- Length at Term(Term corrected age (as close as possible to due date))
- Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks(Term plus 6 weeks corrected age)
- Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks(Term plus 6 weeks corrected age)
- Blood Quantitative Insulin Sensitivity Check Index (QUICKI)(Measured at 35 weeks Post Menstrual Age)