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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Premature Birth of Newborn Enterocolitis, Necrotizing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ampicillin

Intervention Type 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

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes