Trial Outcomes & Findings for Newborn Feeding and Infant Phenotype (NCT NCT02033005)
NCT ID: NCT02033005
Last Updated: 2022-11-15
Results Overview
Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
Recruitment status
COMPLETED
Target enrollment
124 participants
Primary outcome timeframe
Between birth and 6-12 weeks age
Results posted on
2022-11-15
Participant Flow
Participants consisted of healthy, full term, appropriate weight-for-gestational age infants from 2 cohorts: recruited between November 1999 and October 2001 at the Hammersmith Hospital, and between March 2010 and May 2012 from the postnatal ward at Chelsea and Westminster Hospital.
Participant milestones
| Measure |
Breastfed Infants
\>80% of feeds consisting of breast milk at both scanning points
|
Mixed-fed Infants
20%-80% of feeds consisting of breast milk.
|
Formula-fed Infants
\>80% of feeds consisting of formula milk at both scanning points
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
9
|
35
|
|
Overall Study
COMPLETED
|
36
|
9
|
25
|
|
Overall Study
NOT COMPLETED
|
44
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Newborn Feeding and Infant Phenotype
Baseline characteristics by cohort
| Measure |
Breastfed Infants
n=36 Participants
\>80% of feeds consisting of breast milk at both scanning points
|
Mixed-fed Infants
n=9 Participants
20%-80% of feeds consisting of breast milk.
|
Formula-fed Infants
n=25 Participants
\>80% of feeds consisting of formula milk at both scanning points
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
13 Days
n=99 Participants
|
2 Days
n=107 Participants
|
16 Days
n=206 Participants
|
13 Days
n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
36 participants
n=99 Participants
|
9 participants
n=107 Participants
|
25 participants
n=206 Participants
|
70 participants
n=7 Participants
|
|
Weight
|
3.647 kg
STANDARD_DEVIATION 0.421 • n=99 Participants
|
3.332 kg
STANDARD_DEVIATION 0.478 • n=107 Participants
|
3.622 kg
STANDARD_DEVIATION 0.595 • n=206 Participants
|
3.598 kg
STANDARD_DEVIATION 0.500 • n=7 Participants
|
|
Length
|
0.533 m
STANDARD_DEVIATION 0.023 • n=99 Participants
|
0.510 m
STANDARD_DEVIATION 0.025 • n=107 Participants
|
0.523 m
STANDARD_DEVIATION 0.025 • n=206 Participants
|
0.527 m
STANDARD_DEVIATION 0.025 • n=7 Participants
|
|
Head circumference
|
36.5 cm
STANDARD_DEVIATION 1.4 • n=99 Participants
|
35.0 cm
STANDARD_DEVIATION 1.7 • n=107 Participants
|
36 cm
STANDARD_DEVIATION 1.6 • n=206 Participants
|
36.1 cm
STANDARD_DEVIATION 1.6 • n=7 Participants
|
|
Total adipose tissue
|
0.710 l
n=99 Participants
|
0.802 l
n=107 Participants
|
0.722 l
n=206 Participants
|
0.718 l
n=7 Participants
|
|
Total adipose tissue mass %
|
17.5 Percentage of mass
n=99 Participants
|
21.3 Percentage of mass
n=107 Participants
|
18.3 Percentage of mass
n=206 Participants
|
18.1 Percentage of mass
n=7 Participants
|
|
Superficial subcutaneous abdominal adipose tissue
|
0.098 Litres
n=99 Participants
|
0.110 Litres
n=107 Participants
|
0.103 Litres
n=206 Participants
|
0.101 Litres
n=7 Participants
|
|
Superficial subcutaneous non-abdominal adipose tissue
|
0.512 Litres
n=99 Participants
|
0.572 Litres
n=107 Participants
|
0.521 Litres
n=206 Participants
|
0.512 Litres
n=7 Participants
|
|
Deep subcutaneous abdominal adipose tissue
|
0.015 Litres
n=99 Participants
|
0.013 Litres
n=107 Participants
|
0.019 Litres
n=206 Participants
|
0.016 Litres
n=7 Participants
|
|
Deep subcutaneous non-abdominal adipose tissue
|
0.012 Litres
n=99 Participants
|
0.012 Litres
n=107 Participants
|
0.013 Litres
n=206 Participants
|
0.013 Litres
n=7 Participants
|
|
Internal abdominal adipose tissue
|
0.017 Litres
n=99 Participants
|
0.022 Litres
n=107 Participants
|
0.017 Litres
n=206 Participants
|
0.017 Litres
n=7 Participants
|
|
Internal non-abdominal adipose tissue
|
0.054 Litres
n=99 Participants
|
0.061 Litres
n=107 Participants
|
0.052 Litres
n=206 Participants
|
0.054 Litres
n=7 Participants
|
|
Total subcutaneous adipose tissue
|
0.633 Litres
n=99 Participants
|
0.718 Litres
n=107 Participants
|
0.654 Litres
n=206 Participants
|
0.644 Litres
n=7 Participants
|
|
Total internal adipose tissue
|
0.070 Litres
n=99 Participants
|
0.084 Litres
n=107 Participants
|
0.069 Litres
n=206 Participants
|
0.070 Litres
n=7 Participants
|
|
Intrahepatocellular lipid
|
0.662 Ratio of CH2 (methylene) to H2O (water)
n=99 Participants
|
1.126 Ratio of CH2 (methylene) to H2O (water)
n=107 Participants
|
1.197 Ratio of CH2 (methylene) to H2O (water)
n=206 Participants
|
0.949 Ratio of CH2 (methylene) to H2O (water)
n=7 Participants
|
PRIMARY outcome
Timeframe: Between birth and 6-12 weeks agePopulation: Reduced participant number for this analysis represents missing data for some infants at one scan point
Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
Outcome measures
| Measure |
Breastfed
n=35 Participants
\>80% of feeds consisting of breastmilk at both scanning points
|
Mixed-fed Infants
n=9 Participants
20%-80% of feeds consisting of breast milk.
|
Formula-fed Infants
n=24 Participants
\>80% of feeds consisting of formula milk at both scanning points
|
|---|---|---|---|
|
Change in Total Adipose Tissue Volume
|
0.718 Litres
Interval 0.508 to 0.938
|
0.901 Litres
Interval 0.452 to 1.053
|
0.775 Litres
Interval 0.532 to 0.971
|
SECONDARY outcome
Timeframe: Between birth and 6-12 weeks agePopulation: Reduced participant number for this analysis represents missing data for some infants at one scan point
Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging
Outcome measures
| Measure |
Breastfed
n=35 Participants
\>80% of feeds consisting of breastmilk at both scanning points
|
Mixed-fed Infants
n=9 Participants
20%-80% of feeds consisting of breast milk.
|
Formula-fed Infants
n=24 Participants
\>80% of feeds consisting of formula milk at both scanning points
|
|---|---|---|---|
|
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
|
-0.07 no unit (ratio)
Interval -0.09 to -0.02
|
-0.06 no unit (ratio)
Interval -0.08 to -0.02
|
-0.03 no unit (ratio)
Interval -0.07 to 0.01
|
SECONDARY outcome
Timeframe: Between birth and 6-12 weeks agePopulation: Reduced number of participants due to missing intrahepatocellular lipid data in some cases
Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy
Outcome measures
| Measure |
Breastfed
n=30 Participants
\>80% of feeds consisting of breastmilk at both scanning points
|
Mixed-fed Infants
n=4 Participants
20%-80% of feeds consisting of breast milk.
|
Formula-fed Infants
n=20 Participants
\>80% of feeds consisting of formula milk at both scanning points
|
|---|---|---|---|
|
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
|
1.192 ratio of CH2 to water
Interval 0.226 to 1.967
|
-0.054 ratio of CH2 to water
Interval -0.672 to 1.837
|
1.095 ratio of CH2 to water
Interval -0.28 to 1.746
|
Adverse Events
Breastfed Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed-fed Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Formula-fed Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place