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Penicillin Antibiotic

Antibiotics for Neonatal Infections (NANO Trial)

Phase 4

Recruiting

Research Sponsored by Michael Morowitz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

We will enroll newborn infants with gestational age of 23-30 weeks 6 days infants at participating study sites will be eligible.

Be younger than 18 years old

Must not have

Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization

Infants born to mothers with previous infant with GBS disease/infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly stool samples will be collected for the first 8 weeks of life and then monthly through death or discharge from the subject's birth hospital , assessed up to 50 weeks.

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether it's better to give antibiotics to extremely low birthweight babies right away or wait to see if they get an infection.

Who is the study for?

The trial is for newborns born at 23-30 weeks gestation, who are clinically stable without signs of infection or severe respiratory issues. It excludes those with major congenital anomalies, infants expected not to survive beyond 72 hours, and babies whose mothers had infections like GBS disease or chorioamnionitis.

What is being tested?

This study tests whether giving antibiotics (Ampicillin and Gentamycin) to extremely low birthweight infants in their first week affects the rates of sepsis, necrotizing enterocolitis, or death compared to a placebo (Normal saline).

What are the potential side effects?

Potential side effects may include reactions to antibiotics such as rash or diarrhea. Long-term use might lead to antibiotic resistance or affect the development of the baby's gut microbiome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My newborn is between 23 and 30 weeks old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant needs medicine or fluids to maintain blood pressure.

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My previous child had a GBS infection.

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I am a mother and I am under 18 years old.

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My baby was born by C-section without labor induction or signs of maternal infection.

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My infant needs a breathing machine and extra oxygen.

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My infant has received antibiotics before being chosen for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly stool samples will be collected for the first 8 weeks of life and then monthly through death or discharge from the subject's birth hospital , assessed up to 50 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly stool samples will be collected for the first 8 weeks of life and then monthly through death or discharge from the subject's birth hospital , assessed up to 50 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly stool samples will be collected for the first 8 weeks of life and then monthly through death or discharge from the subject's birth hospital , assessed up to 50 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite incidence of NEC, LOS, or death

Secondary study objectives

Death

LOS

NEC

Other study objectives

Microbial diversity within infant fecal samples

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Empiric antibioticsActive Control2 Interventions

Infants will receive standard antibiotic coverage of ampicillin and gentamycin at site approved dosing guidelines while completing an evaluation for early-onset neonatal sepsis.

Group II: PlaceboPlacebo Group1 Intervention

Infants will receive a volume matched placebo of normal saline while completing an evaluation for early-onset neonatal sepsis.

0 / 7Eligibility criteria met