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Antibiotics for Neonatal Infections (NANO Trial)
NANO Trial 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.
NANO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNANO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NANO Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Empiric antibiotics
- Group 2: Placebo
- 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.
- 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.
Frequently Asked Questions
What criteria must potential participants satisfy to be accepted into this research project?
"This clinical study aims to recruit 802 participants between 23 weeks and 4 hours who were born prematurely. Eligible patients must have been gestated for a period of 23-28 weeks in utero by mothers aged 18 or above, and be inborn at corresponding sites."
What is the overall enrollment size for this clinical trial?
"Affirmative, the information posted on clinicaltrials.gov suggests that this medical trial is currently looking for participants. It was initially made available to the public on August 5th 2020 and its parameters have been updated as recently as July 28th 2022. This research requires 802 patients to be recruited from 13 different healthcare facilities."
What types of illnesses does Empiric antibiotics generally target?
"Empiric antibiotics are primarily prescribed to treat listeriosis, but can also provide relief from bacterial infections such as those in the respiratory or gastrointestinal system."
What other empirical antibiotic experiments have been conducted?
"Empiric antibiotics were initially researched at Hadassah Medical Organisation in 2014. Since then, a total of 275 trials have concluded and seven are currently running, primarily located in Pittsburgh, Pennsylvania."
How many medical facilities are participating in this research endeavor?
"Patients for this medical study are being enrolled at Magee Womens Hospital in Pittsburgh, Pennsylvania, Penn State Medical College in Hershey, Missouri, Children's Mercy in Kansas City and 13 other sites."
Does the age limit for eligibility extend beyond 30 years old?
"This medical trial is recruiting participants aged between 23 weeks and 4 hours."
Is the research team currently accepting participants for this experiment?
"According to the clinical trials registry, this medical study is actively recruiting. It was initially posted on August 5th 2020 and most recently updated on July 28th 2022."
Has the FDA sanctioned the use of Empiric antibiotics?
"The safety of empiric antibiotics can be rated 3 out of 3 due to it being in a Phase 4 trial, which indicates that the drug has been approved."
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