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Short- and Long-Term Effects of Antibiotics on Childhood Growth (ABX)

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ClinicalTrials.gov Identifier: NCT02744846
Recruitment Status : Active, not recruiting
First Posted : April 20, 2016
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Patient-Centered Clinical Research Network (PCORnet)
ADVANCE CDRN
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
Greater Plains Collaborative (GPC)
Mid-South Clinical Data Research Network
New York City Clinical Data Research Network
OneFlorida Clinical Research Consortium
PEDSnet: A Pediatric Learning Health System CDRN
PORTAL CDRN
Research Action for Health Network (REACHnet)
Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)
Genetic Alliance
StatLog
Information provided by (Responsible Party):
Jason Block, Harvard Pilgrim Health Care

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.


Condition or disease Intervention/treatment
Obesity Drug: Antibiotics exposure

Detailed Description:

Antibiotics are among the most valuable medical discoveries. Recent research on understanding of how bacteria in our gut use energy, however, raises concerns about whether broad-spectrum antibiotics, which are over-prescribed for mild infections, prescribed in early infancy may cause obesity during childhood. Obesity is a very common and serious condition among US children, particularly children from disadvantaged populations. Past studies examining the link between antibiotic use and childhood obesity are too small and they lack diversity as well as modern scientific tools to gauge the extent to which prescribing antibiotics can lead to excess weight gain. PCORnet, the National Patient-Centered Clinical Research Network, comprising very large networks of data from electronic medical records, provides an ideal test bed to address this question. Further, it is not clear how caregivers and clinicians will use the results of earlier studies to decide which antibiotics to prescribe when faced with common infections like ear infections.

Specific Aim 1: To evaluate the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on body mass index and risk of obesity at ages 5 (primary outcome age) and 10 (secondary) years. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and both higher BMI and the probability of obesity at ages 5 and 10 years. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.

Specific Aim 2: To assess the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on the rates and patterns of childhood growth during the first 5 years of life. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and subsequent growth trajectories of children in a pattern that increases children's risk of later overweight and obesity. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.

Specific Aim 3: To explore how the effects of different types, timing, and amount of antibiotics on childhood BMI, obesity risk and growth (Aims 1 and 2) vary according to patient socio-demographic, clinical, and maternal characteristics, including: 1) socio-demographic (Child sex, Child race/ethnicity, Geography, based on location of clinical facility); 2) Clinical (Prescription of medications that also cause obesity, esp. corticosteroids, Low birth weight or macrosomia in term infants); 3) Maternal for the subset of data partners listed in section B above that have linked maternal and child records (BMI, Maternal receipt of antibiotics during pregnancy, Type of delivery, i.e., Cesarean v. vaginal). Hypotheses: The antibiotic effects will not vary by socio-demographic or maternal characteristics. Long-term corticosteroid use will potentiate the effect of antibiotics on childhood obesity.

Secondary Aim: Through focus groups and in-depth interviews, to explore how parents and other caregivers and their providers assess information related to current and future benefits and risks, particularly for treatments such as antibiotics in early childhood, which can have substantial near-term benefits along with moderate long-term risks. The investigators will also explore how clinicians, health care organizations, and policy makers should best present study findings to help parents understand its strengths and limitations in the context of shared clinical decision-making.


Study Type : Observational
Actual Enrollment : 681739 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Patient-Centered Outcomes Research Network (PCORnet) Obesity Observational Study: Short- and Long-Term Effects of Antibiotics on Childhood Growth
Study Start Date : February 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Change from Baseline Body Mass Index (BMI, kg/m2) at 5 years [ Time Frame: 5 years ]
    BMI measured at 5 years

  2. Change from Baseline Body Mass Index (BMI, kg/m2) at 10 years [ Time Frame: 10 years ]
    BMI measured at 10 years



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  1. 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 months, 12-30 months, and
  2. 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:

1. Biologically implausible length/height or weight measurements


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744846


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

Responsible Party: Jason Block, Assistant Professor, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT02744846     History of Changes
Other Study ID Numbers: OBS-1505-30699
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared publicly per Patient-Centered Outcomes Research Institute (PCORI) regulations 12 months after study completion. De-identified individual level data and aggregate data will be shared.

Keywords provided by Jason Block, Harvard Pilgrim Health Care:
antibiotics
children
pediatric
body mass index
Observational Study
Comparative Effectiveness Research
Obesity
Growth Trajectory
Cohort Study
Electronic Medical Record
Qualitative Research

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents