N/A
N=681,739
Short- and Long-Term Effects of Antibiotics on Childhood Growth
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02744846 ↗Enrolled (actual)
681,739
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months — 0.04; 0.06; 0.04; 0.07 BMI z-score units
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Antibiotics exposure (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Harvard Pilgrim Health Care
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months |
0.04; 0.06; 0.04; 0.07; 0.02; 0.03 | — |
| PRIMARY Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months |
0.03; 0.09; 0.04; 0.08; 0.02; 0.08 | — |
Summary
The objectives of the proposed study are to assess the effects of different types, timing, and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to age 5 years. In Specific Aim 3, the investigators will address how big the effects of antibiotics on obesity are within subgroups of the population, such as different racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.
The data for this study will come from electronic medical records of about 600,000 children from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the United States. The investigators will get information on antibiotic prescribing in the first two years of life, then "virtually" follow these children to ages 5 and 10 years to see what their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index exceeding the 95th percentile for age and sex).
In the main analyses, the CDRNs will not send any individual data to a central site. Rather, using sophisticated computer programs, the study's coordinating center will send "questions to the data," thus protecting the privacy of patients' and the healthcare systems' records. In some analyses, to check how well this "distributed research network" approach works, we will work with individual records whose identifying information has been stripped off ("de-identified data").
In our Secondary Aim, the investigators will employ focus groups of parents and in-depth interviews with clinicians to explore how best to put the findings into everyday practice.
Throughout the study, in addition to employing privacy-protecting approaches to analyzing and sharing data, the investigators will adhere to principles of inclusion, patient-centeredness, stakeholder engagement, effective governance, and protection of human subjects. At the end of the two-year project, the investigators will propose avenues for dissemination of the scientific findings and other products.
Eligibility Criteria
Inclusion Criteria
- 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 months, 12-30 months, and
- 1 or more encounters with height and weight measured after 24 months of age (need 1 or more measure at 4.0-5.9 years for the 5 year outcome and 1 or more measure at 9.0 to 10.9 years for the 10 year outcome), or eligible to be followed to these ages using multiple imputation to account for missing data.
Exclusion Criteria
- Biologically implausible length/height or weight measurements
Data sourced from ClinicalTrials.gov (NCT02744846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.