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

Premature Birth of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477423
• Other study ID #: IRB15-0053
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2019

Study information

• Verified date: September 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Premature Birth
• Premature Birth of Newborn

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center - Comer Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Chronic Lung Disease of Infancy (CLD)	Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation	4-12 weeks
Secondary	Necrotizing Enterocolitis (NEC)	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).	4-12 weeks
Secondary	Retinopathy of Prematurity (ROP)	Cases of ROP as diagnosed by the pediatric ophthalmologist	4-12 weeks
Secondary	Intraventricular Hemorrhage (IVH)	Cases of IVH present on any head ultrasound obtained during patient's hospitalization	4-12 weeks
Secondary	Death		18 months