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NCT03997266 · ClinicalTrials.gov registry record · Phase 4
NICU Antibiotics and Outcomes Trial
A Phase 4 study of Microbial Colonization and Extreme Prematurity, sponsored by Michael Morowitz.
- Active
- Registry status
- Phase 4
- Development phase
- 802
- Enrollment target
- 14
- Study locations
NCT03997266 is a Phase 4 study of Microbial Colonization and Extreme Prematurity that is active but no longer recruiting, run by Michael Morowitz. The registered enrollment target is 802 participants, below the 12,615-participant average among 20 other Microbial Colonization trials with a reported enrollment target (94% lower). The trial reports 14 study locations across 9 states.
The verdict
NCT03997266, a Phase 4 study of Microbial Colonization and Extreme Prematurity, is active but no longer recruiting, sponsored by Michael Morowitz.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 802 participants
- Enrollment target
- 14
- Study locations
Study Summary
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Ampicillin
- DRUG Gentamycin
Study Locations (14)
Pennsylvania
- Penn State Medical College - Hershey
- Pennsylvania Hospital/The Children's Hospital of Philadelphia - Philadelphia
- Alfred I. duPont for Children of the Nemours Foundation - Philadelphia
- Magee Womens Hospital - Pittsburgh
New York
- The Trustees of Columbia University in the City of New York - New York
- Golisano Children's Hospital at University of Rochester - Rochester
- Maria Fareri Children's Hospital at Westchester Medical Center - Valhalla
Alabama
- USA Children's and Women's Hospital - Mobile
California
- Sharp Mary Birch Hospital for Women & Newborns - San Diego
Connecticut
- Yale University School of Medicine - New Haven
Florida
- University of South Flordia Health - Tampa
Kentucky
- University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit - Louisville
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03997266
The ClinicalTrials.gov registry entry for NCT03997266 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 802 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,615-participant average among 20 other Microbial Colonization trials with a reported enrollment target (94% lower). The listed sponsor is Michael Morowitz, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Microbial Colonization appearing as the primary indexed condition, and to 3 interventions - of which Normal saline is the first listed.
NCT03997266 reports 14 study locations spanning 9 distinct geographic areas - top geographies include Pennsylvania, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT03997266 about?
NCT03997266 is a clinical study titled "NICU Antibiotics and Outcomes Trial". The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tes...
What is the current status of trial NCT03997266?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 802 participants. The study started on 2020-08-05. Estimated completion is 2027-06-01.
What conditions does trial NCT03997266 study?
This clinical trial studies the following conditions: Microbial Colonization, Extreme Prematurity, Death; Neonatal, Late-Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn.
What interventions are being tested in trial NCT03997266?
The interventions under investigation include: Normal saline (DRUG), Ampicillin (DRUG), Gentamycin (DRUG).
Who is sponsoring clinical trial NCT03997266?
This trial is sponsored by Michael Morowitz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03997266 being conducted?
This trial has 14 study locations across Alabama, California, Connecticut, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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