Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotic Stewardship and Protection of the Developing 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 : Unknown
Verified July 2017 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : June 22, 2015
Last Update Posted : July 14, 2017
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)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Antibiotic Stewardship and Protection of the Developing Preterm Infant Microbiome
Study Start Date : July 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Ampicillin

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.

Routine, non-randomized care
The infants within this arm of the study were consented, but did not meet the inclusion criteria as being low risk after the time of birth. They will receive all care per the primary medical team. 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.




Primary Outcome Measures :
  1. Development of the preterm infant microbiome [ Time Frame: 18 months ]
    The development of the preterm infant microbiome will be compared between groups through 16S ribosomal ribonucleic acid (rRNA) gene-based analysis of the infants stools.


Secondary Outcome Measures :
  1. Clinical outcome - Chronic Lung Disease (CLD) [ Time Frame: 4-12 weeks ]
    Presence or absence of diagnosis at time of discharge from the hospital

  2. Clinical outcome - Retinopathy of Prematurity (ROP) [ Time Frame: 4-12 weeks ]
    Presence or absence of diagnosis at time of discharge from the hospital

  3. Clinical outcome - Intraventricular Hemorrhage (IVH) [ Time Frame: 4-12 weeks ]
    Presence or absence of diagnosis at time of discharge from the hospital

  4. Clinical outcome - Necrotizing enterocolitis [ Time Frame: 4-12 weeks ]
    Presence or absence of diagnosis at time of discharge from the hospital

  5. Clinical outcome - Death [ Time Frame: 18 months ]
    Survival from the neonatal intensive care unit, and survival beyond discharge will be determined via survey

  6. Length of hospital stay [ Time Frame: Anticipated to be 4-12 weeks ]
    Length of stay (in days) will be determined from the medical record

  7. Number of days from birth to initiation of feeds will be determined from the medical record [ Time Frame: Varies based on gestational age - 0 to 2 weeks ]
  8. Type of feeds (formula compared to breastmilk) during hospitalization. [ Time Frame: 18 months ]
    Post-discharge data will be collected via survey.

  9. The number of times that feeds are held/discontinued due to feeding intolerance will be determined from the medical record. [ Time Frame: 4-12 weeks ]
  10. The total number of days the infant is on antibiotics will be determined from the medical record at the time of discharge. [ Time Frame: 4-12 weeks ]


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


Contacts
Layout table for location contacts
Contact: Nicole Grady, MD 773-702-6210 nicole.grady@uchospitals.edu
Contact: Erika Claud, MD 773-702-6210 eclaud@peds.bsd.uchicago.edu

Locations
Layout table for location information
United States, Illinois
University of Chicago Medical Center - Comer Children's Hospital Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02477423     History of Changes
Other Study ID Numbers: IRB15-0053
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
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
Anti-Infective Agents
Premature Birth
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Bacterial Agents
Gentamicins
Ampicillin
Antibiotics, Antitubercular
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action