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

The University of Chicago

Status: Completed

Conditions: Premature Birth of Newborn; Enterocolitis, Necrotizing

Treatments: Drug: Placebo; Drug: Ampicillin; Drug: Gentamicins

Study type: Interventional

Funder types: Other

Identifiers

NCT02477423

IRB15-0053

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: Under 6 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Randomized & Blinded - Receiving Antibiotics

Active Comparator group

Description:

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.

Treatment:

Drug: Gentamicins

Drug: Ampicillin

Randomized & Blinded - Receiving Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo