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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

NANO-FU 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.Check my eligibility

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.See study design

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.

NANO-FU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months corrected gestational age

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DOOR probability Distribution

Rate of neurodevelopmental impairment or Death

NANO-FU 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sharp HealthCareLead Sponsor

40 Previous Clinical Trials

16,342 Total Patients Enrolled

6 Trials studying Premature Birth

3,532 Patients Enrolled for Premature Birth

University of PittsburghOTHER

1,719 Previous Clinical Trials

16,341,539 Total Patients Enrolled

8 Trials studying Premature Birth

3,328 Patients Enrolled for Premature Birth

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

Premature 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

Premature 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this clinical experiment limited to those over 20 years of age?

"The eligibility requirements for this experiment state that participants must be between 23 and 30 Weeks old. For those under 18 or over the age of 65, there are 183 and 82 respectively trials available."

Answered by AI

Am I qualified to join this experimental program?

"Eligibility for this trial is limited to individuals who were born prematurely between 23 and 30 weeks gestation. As of now, the researchers are searching for 802 participants."

Answered by AI

How widely is this trial being implemented across healthcare centers?

"This trial is available across 15 medical centres in the United States, ranging from Yale University to the University of Louisville. These sites also include locations such as the University of South Florida and 12 other institutions."

Answered by AI

What potential adverse effects have been noted in Very preterm infants that receive empiric antibiotic treatment within two days of birth?

"Based on the available evidence, our team at Power assigns a score of 3 to Very preterm infants that receive empiric antibiotic treatment within 48 hours of birth due to Phase 3 trial results demonstrating efficacy and safety."

Answered by AI

Is there any availability for individuals to join this experimentation?

"This research project, which was first posted on April 1st 2024 and last updated July 28th 2023 is not presently recruiting for patients. However, there are 262 other medical studies in progress that require participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NICU Antibiotics and Outcomes (NANO) Follow-up Study

Anup Katheria, M.D. 2024. "NICU Antibiotics and Outcomes (NANO) Follow-up Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05977400.