Trial Outcomes & Findings for Antecedents of Obesity: Fetal Measures of Adiposity (NCT NCT00715754)
NCT ID: NCT00715754
Last Updated: 2018-01-23
Results Overview
Adiposity as measured by air displacement plethysmography
Recruitment status
COMPLETED
Target enrollment
47 participants
Primary outcome timeframe
24-72 hours following birth
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
All Infants
One group comprised all infants evaluated.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antecedents of Obesity: Fetal Measures of Adiposity
Baseline characteristics by cohort
| Measure |
Infants
n=47 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24-72 hours following birthAdiposity as measured by air displacement plethysmography
Outcome measures
| Measure |
Newborn Infants
n=47 Participants
Newborn Infants
|
|---|---|
|
Infant Adiposity at 24-72 Hours Following Birth
|
11 Percentage of total body weight
Interval 3.0 to 21.0
|
PRIMARY outcome
Timeframe: 35 weeks gestationFetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.
Outcome measures
| Measure |
Newborn Infants
n=47 Participants
Newborn Infants
|
|---|---|
|
Fetal Abdominal Circumference
|
32.6 cm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 35 weeks gestationEstimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.
Outcome measures
| Measure |
Newborn Infants
n=47 Participants
Newborn Infants
|
|---|---|
|
Estimated Fetal Weight Percentile
|
60.8 Percentile
Standard Deviation 4.7
|
Adverse Events
All 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