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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months corrected gestational age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months corrected gestational age
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
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Morgan Stanley Children's HospitalOTHER
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11,346 Total Patients Enrolled
University of LouisvilleOTHER
348 Previous Clinical Trials
76,576 Total Patients Enrolled
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
5,767 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,032 Total Patients Enrolled
Jefferson Medical College of Thomas Jefferson UniversityOTHER
12 Previous Clinical Trials
13,068 Total Patients Enrolled
University of South FloridaOTHER
427 Previous Clinical Trials
191,829 Total Patients Enrolled
Westchester Medical CenterOTHER
7 Previous Clinical Trials
671 Total Patients Enrolled
Yale UniversityOTHER
1,930 Previous Clinical Trials
3,032,656 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant needs a ventilator to breathe and requires a high level of oxygen.My infant is at low risk for early onset sepsis.My infant is at high risk for early onset sepsis.My doctor is worried I or my baby might have an infection based on our symptoms or medical history.My infant needs medicine to maintain blood pressure or received more than one fluid injection for stability.My newborn was born between 23.0-30.6 weeks of gestation at a study site.My infant has received antibiotics before being assigned to a study group.
Research Study Groups:
This trial has the following groups:- Group 1: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
- Group 2: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.