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Anti-bacterial agents

Antibiotics for Neurodevelopmental Outcomes in Preterm Infants (NANO-FU Trial)

Phase 3
Waitlist Available
Led By Anup Katheria, MD
Research Sponsored by Sharp HealthCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months corrected gestational age
Awards & highlights
Pivotal Trial

Summary

This trial will assess if withholding antibiotics at birth reduces neurological/behavioral issues in kids, using genomic data & microbiota research.

Who is the study for?
The NANO follow-up study is for families enrolled in the original NANO trial, which involves premature infants. It's not for low-risk infants or those with conditions like high risk of sepsis, respiratory issues requiring significant support, hemodynamic instability, major congenital anomalies, or prior antibiotic use.
What is being tested?
This study tests whether withholding antibiotics from premature babies at birth can reduce neurodevelopmental disorders by age two. It compares outcomes between babies given Gentamicin and Ampicillin versus a placebo while considering genetic factors and gut bacteria.
What are the potential side effects?
While specific side effects are not listed here, common reactions to antibiotics like Gentamicin and Ampicillin include allergic reactions, digestive upset, and potential impacts on the balance of gut bacteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months corrected gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DOOR probability Distribution
Rate of neurodevelopmental impairment or Death

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of lifeActive Control2 Interventions
Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of empiric antibiotic treatment.
Group II: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of lifePlacebo Group1 Intervention
Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.

Find a Location

Who is running the clinical trial?

Sharp HealthCareLead Sponsor
40 Previous Clinical Trials
16,369 Total Patients Enrolled
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,358,821 Total Patients Enrolled
Morgan Stanley Children's HospitalOTHER
6 Previous Clinical Trials
11,346 Total Patients Enrolled

Media Library

Ampicillin (Anti-bacterial agents) Clinical Trial Eligibility Overview. Trial Name: NCT05977400 — Phase 3
Preterm Birth Research Study Groups: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life, Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
Preterm Birth Clinical Trial 2023: Ampicillin Highlights & Side Effects. Trial Name: NCT05977400 — Phase 3
Ampicillin (Anti-bacterial agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977400 — Phase 3
~535 spots leftby Mar 2029
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