We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02477423
Recruitment Status : Completed
First Posted : June 22, 2015
Results First Posted : September 3, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Premature Birth of Newborn Enterocolitis, Necrotizing Drug: Ampicillin Drug: Gentamicins Drug: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Study Start Date : July 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019


Arm Intervention/treatment
Active Comparator: Randomized & Blinded - Receiving Antibiotics
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
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.

Drug: Gentamicins
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.

Placebo Comparator: Randomized & Blinded - Receiving Placebo
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
Normal saline will be given as placebo for those in the placebo comparator group.




Primary Outcome Measures :
  1. Richness of the Preterm Infant Microbiome [ Time Frame: 2 weeks ]
    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. Shannon Diversity of the Preterm Infant Microbiome [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Chronic Lung Disease of Infancy (CLD) [ Time Frame: 4-12 weeks ]
    Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation

  2. Necrotizing Enterocolitis (NEC) [ Time Frame: 4-12 weeks ]
    Any patient showing signs/symptoms of this acute neonatal gastrointestinal disease, including abdominal distension, bloody stools, systemic illness, and radiographic changes (pneumatosis intestinalis, portal venous gas, free intraperitoneal gas).

  3. Retinopathy of Prematurity (ROP) [ Time Frame: 4-12 weeks ]
    Cases of ROP as diagnosed by the pediatric ophthalmologist

  4. Intraventricular Hemorrhage (IVH) [ Time Frame: 4-12 weeks ]
    Cases of IVH present on any head ultrasound obtained during patient's hospitalization

  5. Death [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for antibiotic randomization:

  1. Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks

    -AND-

  2. Infant must be born at investigator's home institution.

    -AND-

  3. Infant must be considered to have a low risk of infection by one of the following criteria:

    1. 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-
    2. Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes >18 hours

Exclusion Criteria for antibiotic randomization:

  1. Signs of clinical illness within the first 3 hours of life:

    1. 5-minute Apgar <5
    2. Requiring vasoactive drugs
    3. Seizures
    4. Significant respiratory distress requiring supplemental oxygen >40%
  2. Immature:Total (I:T) Ratio of >0.2 on initial complete blood count (CBC)
  3. Congenital anomalies, including renal anomalies requiring serum antibiotic level monitoring

ANY infant born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks who do not meet inclusion criteria, with parental consent, can participate in the stool analysis only arm of the study.


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): NCT02477423


Locations
Layout table for location information
United States, Illinois
University of Chicago Medical Center - Comer Children's Hospital
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Study Protocol  [PDF] August 30, 2018
No Statistical Analysis Plan (SAP) exists for this study.

Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02477423    
Other Study ID Numbers: IRB15-0053
First Posted: June 22, 2015    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
Microbiome
Antibiotics
Additional relevant MeSH terms:
Layout table for MeSH terms
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gentamicins
Ampicillin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action