Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
Conditions
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.
Interventions
OTHERUnfortified Human donor Milk used to make up any shortfall in mother's own milk
OTHERFortified Human donor Milk used to make up any shortfall in mother's own milk
OTHERPreterm Formula used when there is a shortfall in mother's own milk
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 31 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Adiposity | 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
| Measure | Time frame | Description |
|---|---|---|
| Consent Rate for Feeding Intervention (Opt Out Approach) | Up to the first 48hrs of life | Consent rate for feeding intervention of number of parents of eligible infants approached and study discussed with (opt out approach) |
| Parental Withdrawal From Feed Intervention | From birth to 35 weeks post menstrual age | Parental withdrawal rate from feed intervention |
| Parental Withdrawal Rate From Feed Intervention by Arm | From birth to 35 weeks post menstrual age | Parental withdrawal rate from feed intervention by feed intervention arm |
| Clinician Refusal to Randomise | Up to the first 48hrs of life. | Attending clinician refusal to randomise eligible infant into feeding intervention |
| Safety Criteria Threshold | Birth to 35 weeks post menstrual age | 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 |
| 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) | Weight at term by feed intervention arm |
| Length at Term | Term corrected age (as close as possible to due date) | Length at term by feed intervention arm |
| Head Circumference at Term | Term corrected age (as close as possible to due date) | Head circumference at term by feed intervention arm |
| Head Circumference at Term Plus 6 Weeks | Term plus 6 weeks | Head circumference at Term plus 6 weeks by feed intervention arm |
| 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) | 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) |
| Weight at Term Plus 6 Weeks | Term plus 6 weeks corrected age | Weight at Term plus 6 weeks by feed intervention arm |
| Length at Term Plus 6 Weeks | Term plus 6 weeks | Length at Term plus 6 weeks by feed intervention group |
| Total Body Adiposity at Term Plus 6 Weeks | 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. |
| Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks | Term plus 6 weeks corrected age | 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. |
| Non Adipose Tissue, 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. 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) |
| Blood Quantitative Insulin Sensitivity Check Index (QUICKI) | Measured at 35 weeks Post Menstrual Age | 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) |
| 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) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unfortified Human Donor Milk Used to make up any shortfall in mother's own milk
Unfortified Human donor Milk used to make up any shortfall in mother's own milk | 35 |
| Fortified 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 | 34 |
| Preterm Formula Used to make up any shortfall in mother's own milk
Preterm Formula used when there is a shortfall in mother's own milk | 34 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Feeding Intervention | Death | 1 | 0 | 1 |
| Feeding Intervention | Met pre-defined safety threshold | 1 | 0 | 1 |
| Feeding Intervention | Physician Decision | 1 | 2 | 0 |
| Feeding Intervention | Transfer to a non-participating hospital | 0 | 1 | 1 |
| Feeding Intervention | Withdrawal by Subject | 0 | 6 | 0 |
| Primary Outcome Term Scan | Lost to Follow-up | 1 | 1 | 1 |
| Primary Outcome Term Scan | Scanner unavailable to measure primary outcome | 2 | 0 | 0 |
| Primary Outcome Term Scan | Withdrawal by Subject | 6 | 5 | 5 |
| Term Plus 6 Week Scan (End of Study) | Lost to Follow-up | 0 | 2 | 0 |
| Term Plus 6 Week Scan (End of Study) | Withdrawal by Subject | 7 | 12 | 5 |
Baseline characteristics
| Characteristic | Unfortified Human Donor Milk | Fortified Human Donor Milk | Preterm Formula | Total |
|---|---|---|---|---|
| Age, Continuous | 29.4 Completed gestational weeks STANDARD_DEVIATION 2.2 | 29.6 Completed gestational weeks STANDARD_DEVIATION 2 | 29.7 Completed gestational weeks STANDARD_DEVIATION 1.7 | 29.5 Completed gestational weeks STANDARD_DEVIATION 1.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 34 Participants | 34 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 35 participants | 34 participants | 34 participants | 103 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 15 Participants | 43 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 19 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 35 | 0 / 34 | 1 / 34 |
| other Total, other adverse events | 0 / 35 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 | 0 / 34 |
Outcome results
Primary
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).
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Total Body Adiposity | 0.893 Litres | Standard Deviation 0.38 |
| Fortified Human Donor Milk | Total Body Adiposity | 0.863 Litres | Standard Deviation 0.26 |
| Preterm Formula | Total Body Adiposity | 0.809 Litres | Standard Deviation 0.25 |
Secondary
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)
Time frame: Measured at 35 weeks Post Menstrual Age
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Blood Quantitative Insulin Sensitivity Check Index (QUICKI) | 0.46 units on a scale | Standard Deviation 0.09 |
| Fortified Human Donor Milk | Blood Quantitative Insulin Sensitivity Check Index (QUICKI) | 0.42 units on a scale | Standard Deviation 0.03 |
| Preterm Formula | Blood Quantitative Insulin Sensitivity Check Index (QUICKI) | 0.45 units on a scale | Standard Deviation 0.09 |
Secondary
Clinician Refusal to Randomise
Attending clinician refusal to randomise eligible infant into feeding intervention
Time frame: Up to the first 48hrs of life.
Population: All eligible participants who consented for feed intervention who were then not randomised due to clinician refusal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unfortified Human Donor Milk | Clinician Refusal to Randomise | 0 Participants |
Secondary
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)
Time frame: Up to the first 48hrs of life
Population: Parents of 165 eligible infants for which the study was discussed with and opportunity offered to opt-out from randomisation to feed intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unfortified Human Donor Milk | Consent Rate for Feeding Intervention (Opt Out Approach) | 103 Participants |
Secondary
Head Circumference at Term
Head circumference at term by feed intervention arm
Time frame: Term corrected age (as close as possible to due date)
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Head Circumference at Term | 35.9 Cm | Standard Deviation 2.4 |
| Fortified Human Donor Milk | Head Circumference at Term | 35.0 Cm | Standard Deviation 1.9 |
| Preterm Formula | Head Circumference at Term | 35.4 Cm | Standard Deviation 2.1 |
Secondary
Head Circumference at Term Plus 6 Weeks
Head circumference at Term plus 6 weeks by feed intervention arm
Time frame: Term plus 6 weeks
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Head Circumference at Term Plus 6 Weeks | 38.76 Cm | Standard Deviation 2.13 |
| Fortified Human Donor Milk | Head Circumference at Term Plus 6 Weeks | 37.89 Cm | Standard Deviation 1.97 |
| Preterm Formula | Head Circumference at Term Plus 6 Weeks | 38.91 Cm | Standard Deviation 2 |
Secondary
Length at Term
Length at term by feed intervention arm
Time frame: Term corrected age (as close as possible to due date)
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Length at Term | 50.0 Cm | Standard Deviation 3.8 |
| Fortified Human Donor Milk | Length at Term | 49.5 Cm | Standard Deviation 3 |
| Preterm Formula | Length at Term | 49.6 Cm | Standard Deviation 3.5 |
Secondary
Length at Term Plus 6 Weeks
Length at Term plus 6 weeks by feed intervention group
Time frame: Term plus 6 weeks
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Length at Term Plus 6 Weeks | 55.70 Cm | Standard Deviation 3.46 |
| Fortified Human Donor Milk | Length at Term Plus 6 Weeks | 55.86 Cm | Standard Deviation 2.87 |
| Preterm Formula | Length at Term Plus 6 Weeks | 55.98 Cm | Standard Deviation 3.7 |
Secondary
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)
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)
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Non Adipose Tissue, as Measured by Whole Body MRI, at Term | 2511.79 Grams | Standard Deviation 502.84 |
| Fortified Human Donor Milk | Non Adipose Tissue, as Measured by Whole Body MRI, at Term | 2385.74 Grams | Standard Deviation 437.81 |
| Preterm Formula | Non Adipose Tissue, as Measured by Whole Body MRI, at Term | 2424.70 Grams | Standard Deviation 462.63 |
Secondary
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)
Time frame: Term plus 6 weeks corrected age
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks | 3263.98 Grams | Standard Deviation 609.89 |
| Fortified Human Donor Milk | Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks | 3208.10 Grams | Standard Deviation 526.21 |
| Preterm Formula | Non Adipose Tissue, as Measured by Whole Body MRI at Term Plus 6 Weeks | 3364.38 Grams | Standard Deviation 634.07 |
Secondary
Parental Withdrawal From Feed Intervention
Parental withdrawal rate from feed intervention
Time frame: From birth to 35 weeks post menstrual age
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unfortified Human Donor Milk | Parental Withdrawal From Feed Intervention | 6 Participants |
Secondary
Parental Withdrawal Rate From Feed Intervention by Arm
Parental withdrawal rate from feed intervention by feed intervention arm
Time frame: From birth to 35 weeks post menstrual age
Population: Parental withdrawal rate from feed intervention by arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unfortified Human Donor Milk | Parental Withdrawal Rate From Feed Intervention by Arm | 0 Participants |
| Fortified Human Donor Milk | Parental Withdrawal Rate From Feed Intervention by Arm | 6 Participants |
| Preterm Formula | Parental Withdrawal Rate From Feed Intervention by Arm | 0 Participants |
Secondary
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.
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)
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Regional Adiposity, as Measured by Whole Body MRI, at Term. | 0.043 Litres | Standard Deviation 0.02 |
| Fortified Human Donor Milk | Regional Adiposity, as Measured by Whole Body MRI, at Term. | 0.044 Litres | Standard Deviation 0.02 |
| Preterm Formula | Regional Adiposity, as Measured by Whole Body MRI, at Term. | 0.040 Litres | Standard Deviation 0.01 |
Secondary
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.
Time frame: Term plus 6 weeks corrected age
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks | 0.064 Litres | Standard Deviation 0.023 |
| Fortified Human Donor Milk | Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks | 0.061 Litres | Standard Deviation 0.025 |
| Preterm Formula | Regional Adiposity, as Measured by Whole Body MRI at Term Plus 6 Weeks | 0.062 Litres | Standard Deviation 0.018 |
Secondary
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
Time frame: Birth to 35 weeks post menstrual age
Population: All participants who consented for feed intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unfortified Human Donor Milk | Safety Criteria Threshold | 1 Participants |
| Fortified Human Donor Milk | Safety Criteria Threshold | 0 Participants |
| Preterm Formula | Safety Criteria Threshold | 1 Participants |
Secondary
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.
Time frame: Term plus 6 weeks
Population: Feed Intervention Arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Total Body Adiposity at Term Plus 6 Weeks | 1.355 Litres | Standard Deviation 0.486 |
| Fortified Human Donor Milk | Total Body Adiposity at Term Plus 6 Weeks | 1.474 Litres | Standard Deviation 0.463 |
| Preterm Formula | Total Body Adiposity at Term Plus 6 Weeks | 1.353 Litres | Standard Deviation 0.284 |
Secondary
Weight at Term
Weight at term by feed intervention arm
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Weight at Term | 3295 Grams | Standard Deviation 798 |
| Fortified Human Donor Milk | Weight at Term | 3185 Grams | Standard Deviation 678 |
| Preterm Formula | Weight at Term | 3153 Grams | Standard Deviation 656 |
Secondary
Weight at Term Plus 6 Weeks
Weight at Term plus 6 weeks by feed intervention arm
Time frame: Term plus 6 weeks corrected age
Population: Feed intervention arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unfortified Human Donor Milk | Weight at Term Plus 6 Weeks | 4564 Grams | Standard Deviation 982 |
| Fortified Human Donor Milk | Weight at Term Plus 6 Weeks | 4594 Grams | Standard Deviation 802 |
| Preterm Formula | Weight at Term Plus 6 Weeks | 4590 Grams | Standard Deviation 820 |