Short- and Long-Term Effects of Antibiotics on Childhood Growth
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Details
Lead Sponsor:
Harvard Pilgrim Health Care
Collaborators:
ADVANCE CDRN Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN) Genetic Alliance Greater Plains Collaborative (GPC) Greater Plains Collaborative Clinical Data Research Network Mid-South Clinical Data Research Network National Patient-Centered Clinical Research Network New York City Clinical Data Research Network OneFlorida Clinical Research Consortium Patient-Centered Outcomes Research Institute PEDSnet: A Pediatric Learning Health System CDRN PORTAL CDRN Research Action for Health Network (REACHnet) Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS) StatLog