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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: Active Phase 4 study of Microbial Colonization and Extreme Prematurity, sponsored by Michael Morowitz.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
NEC will be assessed by clinical presentation and an abdominal x-ray obtained and read by a certified radiologist. NEC will be defined strictly by Bell's stage II or III criteria for moderate or advanced NEC. To reduce overlap between NEC and diagnosis of spontaneous intestinal perforation, the diagnosis of NEC will only be considered in infants \> 7 days of age. LOS is defined as defined as a positive blood culture obtained after 72 hours of life and intent to treat with antibiotics for 5 days
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 |
What the registry record for NCT03997266 still lists
NCT03997266 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, below the 12,615-participant average among 20 other Microbial Colonization trials with a reported enrollment target (94% lower).
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 lists 14 locations in 9 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03997266's enrollment target sits among peer trials
802 2nd of 20 the highest of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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