Short- and Long-Term Effects of Antibiotics on Childhood Growth

NCT02744846 | Completed Results

• 1 other identifier: OBS-1505-30699
• Study Type: observational
• Target: 681,739
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Keywords

antibiotics; children; pediatric; body mass index; Observational Study; Comparative Effectiveness Research; Obesity; Growth Trajectory; Cohort Study; Electronic Medical Record; Qualitative Research

Outcome Measures

Primary Outcomes (2)

• Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months

  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.

  48-72 Months

• Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months

  BMI 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.

  10 years

Study Arms (2)

Children from birth to 5 years

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

Drug: Antibiotics exposure

Children from birth to 10 years

Children from birth to 10 years where: 1. 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 m, 12-30 m, and 2. \> 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y ("age 10 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data.

Drug: Antibiotics exposure

Interventions

Antibiotics exposure DRUG

Children from birth to 10 years; Children from birth to 5 years

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population will include children from age 0 to age 11 years. The population will be identified using data from participating sites formatted into the PCORnet Common Data Model (CDM).

You may qualify if:

• or more encounters with length and weight measured in each of the following age intervals: 0-12 months, 12-30 months, and
• 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.

You may not qualify if:

• \. Biologically implausible length/height or weight measurements

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Patient-Centered Outcomes Research Institute: collaborator
• National Patient-Centered Clinical Research Network: collaborator
• ADVANCE CDRN: collaborator
• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN): collaborator
• Greater Plains Collaborative Clinical Data Research Network: collaborator
• Mid-South Clinical Data Research Network: collaborator
• New York City Clinical Data Research Network: collaborator
• OneFlorida Clinical Research Consortium: collaborator
• PEDSnet: A Pediatric Learning Health System CDRN: collaborator
• PORTAL CDRN: collaborator
• Research Action for Health Network (REACHnet): collaborator
• Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): collaborator
• Genetic Alliance: collaborator
• StatLog: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jason Block
• Organization: Harvard Pilgrim Health Care Institute

jblock1@partners.org

6178674841

Study Officials

• Jason P Block, MD, MPH

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

• Christopher B Forrest, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Douglas Lunsford

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 20, 2019
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share