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

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

Interventions

DRUG

Antibiotics exposure

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• National Patient-Centered Clinical Research Network

  collaborator OTHER

• ADVANCE CDRN

  collaborator UNKNOWN

• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)

  collaborator OTHER

• Greater Plains Collaborative Clinical Data Research Network

  collaborator OTHER

• Mid-South Clinical Data Research Network

  collaborator OTHER

• New York City Clinical Data Research Network

  collaborator OTHER

• OneFlorida Clinical Research Consortium

  collaborator OTHER

• PEDSnet: A Pediatric Learning Health System CDRN

  collaborator UNKNOWN

• PORTAL CDRN

  collaborator UNKNOWN

• Research Action for Health Network (REACHnet)

  collaborator OTHER

• Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)

  collaborator UNKNOWN

• Genetic Alliance

  collaborator OTHER

• StatLog

  collaborator UNKNOWN

• Harvard Pilgrim Health Care

  lead OTHER

Principal Investigators

• Jason P Block, MD, MPH · Harvard Pilgrim Health Care Institute

• Christopher B Forrest, MD, PhD · Children's Hospital of Philadelphia

• Douglas Lunsford · Nationwide Children's Hospital

Eligibility

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-12-31

Completion

2018-12-31