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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 belowSelect...
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:Select...
My infant needs medicine or fluids to maintain blood pressure.
Select...
My previous child had a GBS infection.
Select...
I am a mother and I am under 18 years old.
Select...
My baby was born by C-section without labor induction or signs of maternal infection.
Select...
My infant needs a breathing machine and extra oxygen.
Select...
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.
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.
Find a Location
Who is running the clinical trial?
Michael MorowitzLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,746,742 Total Patients Enrolled
6 Trials studying Neonatal Sepsis
64,612 Patients Enrolled for Neonatal Sepsis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant needs medicine or fluids to maintain blood pressure.My previous child had a GBS infection.My baby might be at high risk for sepsis based on their or my medical history.I am a mother and I am under 18 years old.My infant is at high risk for early-onset sepsis.You were born with significant birth defects or abnormalities.My baby was born by C-section without labor induction or signs of maternal infection.My infant needs a breathing machine and extra oxygen.My newborn is between 23 and 30 weeks old.My infant has received antibiotics before being chosen for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Empiric antibiotics
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
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.