Trial Outcomes & Findings for Impact of Body Weight on the Immediate Health of the Pediatric Population (NCT NCT00267631)
NCT ID: NCT00267631
Last Updated: 2013-08-12
Results Overview
The Children visiting the ED having an infectious disease
Recruitment status
COMPLETED
Target enrollment
5392 participants
Primary outcome timeframe
30 minutes
Results posted on
2013-08-12
Participant Flow
Pediatric Emergency Department
No significant events
Participant milestones
| Measure |
At Risk Body Weight
Children with BMI greater and equal to 85%
|
NOrmal Body Weight
Children with BMI of 25-75%
|
|---|---|---|
|
Overall Study
STARTED
|
2361
|
3031
|
|
Overall Study
COMPLETED
|
2361
|
3031
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Body Weight on the Immediate Health of the Pediatric Population
Baseline characteristics by cohort
| Measure |
At Risk Body Weight
n=3031 Participants
Children with BMI greater adn equal to 85%
|
Normal Body Weight
n=2361 Participants
Children with a BMI of 25 to 75%
|
Total
n=5392 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3031 Participants
n=93 Participants
|
2361 Participants
n=4 Participants
|
5392 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
9.2 years
STANDARD_DEVIATION 4.3 • n=93 Participants
|
8.8 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 4.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1229 Participants
n=93 Participants
|
1031 Participants
n=4 Participants
|
2260 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1802 Participants
n=93 Participants
|
1330 Participants
n=4 Participants
|
3132 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3031 participants
n=93 Participants
|
2361 participants
n=4 Participants
|
5392 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThe Children visiting the ED having an infectious disease
Outcome measures
| Measure |
At Risk Body Weight
n=2361 Participants
Children with BMI greater and equal to 85%
|
Normal Body Weight
n=3031 Participants
Children with BMI of 25-75%
|
|---|---|---|
|
Diagnosis of Infectious Disease
|
900 Participants
|
1067 Participants
|
Adverse Events
At Risk Body Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Body Weight
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
Dr. Estevan Garcia, MD; Principal Investigator
Maimonides Medical Center
Phone: 718-283-6352
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place