A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

NCT02477423 | Completed Results DMC

• 1 other identifier: IRB15-0053
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.

Conditions

Premature Birth of Newborn; Enterocolitis, Necrotizing

Keywords

Microbiome; Antibiotics

Outcome Measures

Primary Outcomes (2)

• Richness of the Preterm Infant Microbiome

  Number of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) detected in each sample. A higher richness means that a higher number of species of archaea and bacteria was detected in a sample.

  2 weeks

• Shannon Diversity of the Preterm Infant Microbiome

  Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.

  2 weeks

Secondary Outcomes (5)

• Chronic Lung Disease of Infancy (CLD)

  4-12 weeks

• Necrotizing Enterocolitis (NEC)

  4-12 weeks

• Retinopathy of Prematurity (ROP)

  4-12 weeks

• Intraventricular Hemorrhage (IVH)

  4-12 weeks

• Death

  18 months

Study Arms (2)

Randomized & Blinded - Receiving Antibiotics

ACTIVE COMPARATOR

The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.

Drug: Ampicillin; Drug: Gentamicins

Randomized & Blinded - Receiving Placebo

PLACEBO COMPARATOR

The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.

Drug: Placebo

Interventions

Ampicillin DRUG

Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.

Randomized & Blinded - Receiving Antibiotics

Gentamicins DRUG

Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.

Randomized & Blinded - Receiving Antibiotics

Placebo DRUG

Normal saline will be given as placebo for those in the placebo comparator group.

Randomized & Blinded - Receiving Placebo

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks
• AND-
• Infant must be born at investigator's home institution.
• AND-
• Infant must be considered to have a low risk of infection by one of the following criteria:
• Delivered for maternal indications (Cesarean section or induction of labor for maternal health, including pre-eclampsia, placental abruption, history of intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm delivery, etc) -OR-
• Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes \>18 hours

You may not qualify if:

• Signs of clinical illness within the first 3 hours of life:
• minute Apgar \<5
• Requiring vasoactive drugs
• Seizures
• Significant respiratory distress requiring supplemental oxygen \>40%
• Immature:Total (I:T) Ratio of \>0.2 on initial complete blood count (CBC)
• Congenital anomalies, including renal anomalies requiring serum antibiotic level monitoring

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center - Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Interventions

Ampicillin; Gentamicins

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Christina S. Kim
• Organization: Neonatology, Department of Pediatrics, University of Chicago

christinakim13@gmail.com

773-702-6210

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 22, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 8, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)