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Completed

NCT Number: NCT02477423

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

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.

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Key information

Conditions

Premature Birth of Newborn Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center - Comer Children's Hospital

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for antibiotic randomization:

  • 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

Exclusion criteria

for antibiotic randomization:

  • Signs of clinical illness within the first 3 hours of life:
  • 5-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

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.

Treatment and study plan

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.

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.

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2015
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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