Trial Outcomes & Findings for Short- and Long-Term Effects of Antibiotics on Childhood Growth (NCT NCT02744846)
NCT ID: NCT02744846
Last Updated: 2019-12-20
Results Overview
BMI z-score measured between 48-72 months Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Recruitment status
COMPLETED
Target enrollment
681739 participants
Primary outcome timeframe
48-72 Months
Results posted on
2019-12-20
Participant Flow
Participant milestones
| Measure |
Children From Birth to 10 Years
Analysis Period 1:
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \>= 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y ("age 5 years")
Analysis Period 2:
Children from birth to 10 years where:
1. Same criteria as above for the 5 year assessment, and
2. \>= 1 encounter with height and weight measured in the following age intervals: 9.0 to 10.9 y ("age 10 years")
|
|---|---|
|
5 Year Outcome Assessment
STARTED
|
681739
|
|
5 Year Outcome Assessment
Excluded Ineligible Patients
|
319189
|
|
5 Year Outcome Assessment
COMPLETED
|
362550
|
|
5 Year Outcome Assessment
NOT COMPLETED
|
319189
|
|
10 Year Outcome Assessment
STARTED
|
362550
|
|
10 Year Outcome Assessment
Exclude Ineligible Patients
|
305820
|
|
10 Year Outcome Assessment
COMPLETED
|
56730
|
|
10 Year Outcome Assessment
NOT COMPLETED
|
305820
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short- and Long-Term Effects of Antibiotics on Childhood Growth
Baseline characteristics by cohort
| Measure |
Children From Birth to 5 Years
n=681 Participants
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \> 1 encounter with height and weight measured in either or both of the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data
Antibiotics exposure
|
|---|---|
|
Age, Customized
Less than 12 months
|
681,739 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
324,864 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
356,875 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
119,059 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
445,878 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
116,802 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2,862 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
28,356 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2,930 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
170,007 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
363,759 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
14,184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
99,641 Participants
n=5 Participants
|
|
Birth-related diagnoses
Prematurity
|
52,752 Participants
n=5 Participants
|
|
Birth-related diagnoses
Heavy for gestational age newborn
|
9,907 Participants
n=5 Participants
|
|
Birth-related diagnoses
Low birth weight
|
5,828 Participants
n=5 Participants
|
|
Birth-related diagnoses
Macrosomia
|
425 Participants
n=5 Participants
|
|
Birth-related diagnoses
No birth diagnosis
|
612,827 Participants
n=5 Participants
|
|
Chronic conditions/categories
Asthma
|
94,399 Participants
n=5 Participants
|
|
Chronic conditions/categories
Cardiovascular
|
46,862 Participants
n=5 Participants
|
|
Chronic conditions/categories
Other congenital defect
|
42,094 Participants
n=5 Participants
|
|
Chronic conditions/categories
Respiratory
|
21,455 Participants
n=5 Participants
|
|
Chronic conditions/categories
Metabolic
|
17,005 Participants
n=5 Participants
|
|
Chronic conditions/categories
Neuromuscular
|
16,906 Participants
n=5 Participants
|
|
Chronic conditions/categories
Renal
|
16,397 Participants
n=5 Participants
|
|
Chronic conditions/categories
Hematological/immunological
|
14,547 Participants
n=5 Participants
|
|
Chronic conditions/categories
Endocrine
|
6,602 Participants
n=5 Participants
|
|
Chronic conditions/categories
Malignant neoplasms
|
6,593 Participants
n=5 Participants
|
|
Chronic conditions/categories
Gastrointestinal
|
6,015 Participants
n=5 Participants
|
|
Chronic conditions/categories
No chronic condition diagnosis
|
392,864 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48-72 MonthsBMI z-score measured between 48-72 months Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Outcome measures
| Measure |
Children With no Complex Chronic Conditions
n=310947 Participants
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data
Antibiotics exposure
|
Children With Complex Chronic Conditions
n=51603 Participants
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data
Antibiotics exposure
|
|---|---|---|
|
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months
Any antibiotics vs. none <24 months of age
|
0.04 BMI z-score units
Interval 0.03 to 0.05
|
0.06 BMI z-score units
Interval 0.04 to 0.09
|
|
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months
Broad spectrum vs. none < 24 months of age
|
0.04 BMI z-score units
Interval 0.03 to 0.05
|
0.07 BMI z-score units
Interval 0.05 to 0.1
|
|
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months
Narrow spectrum vs. non <24 months of age
|
0.02 BMI z-score units
Interval 0.01 to 0.03
|
0.03 BMI z-score units
Interval -0.01 to 0.06
|
PRIMARY outcome
Timeframe: 10 yearsBMI measured at 10 years Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Outcome measures
| Measure |
Children With no Complex Chronic Conditions
n=48785 Participants
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data
Antibiotics exposure
|
Children With Complex Chronic Conditions
n=7945 Participants
Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. \> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data
Antibiotics exposure
|
|---|---|---|
|
Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months
Any antibiotics vs. none <24 months of age
|
0.03 BMI z-score units
Interval 0.01 to 0.06
|
0.09 BMI z-score units
Interval 0.03 to 0.15
|
|
Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months
Broad spectrum vs. none < 24 months of age
|
0.04 BMI z-score units
Interval 0.01 to 0.06
|
0.08 BMI z-score units
Interval 0.02 to 0.14
|
|
Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months
Narrow spectrum vs. non <24 months of age
|
0.02 BMI z-score units
Interval -0.01 to 0.05
|
0.08 BMI z-score units
Interval -0.01 to 0.17
|
Adverse Events
Children From Birth to 5 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children From Birth to 10 Years
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