Microbiome, Antibiotics, and Growth Infant Cohort

NCT03001167 | Completed

• 2 other identifiers: 15-012623R01AI121383
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.

Conditions

Obesity, Childhood; Antibiotic Side Effect

Keywords

Microbiome; Antibiotics; Growth

Outcome Measures

Primary Outcomes (2)

• cumulative microbial diversity

  24 months

• weight trajectory adjusted for time varying length

  24 months

Secondary Outcomes (7)

• total number of individual bacterial taxa

  24 months

• expression levels of bacterial gene categories

  24 months

• fat stores in the upper arm/extremity

  24 months

• fat stores in the upper back/trunk

  24 months

• supine length trajectory

  24 months

Eligibility Criteria

• Age: Up to 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Our study population will be comprised of children born at Pennsylvania Hospital between 2016-2018 and subsequently, followed in the Children's Hospital of Philadelphia (CHOP) Care Network or one of four other local primary care pediatric practices.

You may qualify if:

• Born at Pennsylvania Hospital
• Recruited at \<120 hours of age
• Born at ≥36 0/7 weeks gestation
• Birth weight ≥2000 grams
• Parents plan to receive well-child care in the Children's Hospital of Philadelphia (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or South Philly Pediatrics
• Biological mother is the legal guardian, or the child is born from a surrogacy with guardianship immediately transferred in hospital

You may not qualify if:

• Child in neonatal intensive care unit (NICU) for \>120 cumulative hours
• Biological mother NOT legal guardian, except surrogacy where guardianship is transferred at birth
• Biological mother NOT primary caretaker, except surrogacy where guardianship is transferred at birth
• Biological mother \< 18 years of age
• Child has culture confirmed (blood or cerebrospinal fluid cultures) infection
• Biological mother is non-English speaking

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Minnesota: collaborator
• University of Pennsylvania: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Official study website

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples Saliva samples nasal swab skin swabs blood draw cord blood heel stick

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffrey S Gerber, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Dan Knights, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 22, 2016
• Study Start: December 9, 2016
• Primary Completion: October 22, 2021
• Study Completion: June 9, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)