Investigating the effects of antibiotics on extremely low birthweight infants
NICU Antibiotics and Outcomes Trial
PHASE4 · University of Pittsburgh · NCT03997266
This study is testing if giving antibiotics to extremely low birthweight infants in their first week of life can help prevent serious infections and other health problems.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 802 (estimated) |
| Ages | N/A to 4 Hours |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 18 sites (Mobile, Alabama and 17 other locations) |
| Trial ID | NCT03997266 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of empirically administered intravenous antibiotics on extremely low birthweight (ELBW) infants during their first week of life. It is a multicenter, placebo-controlled, randomized trial involving 802 subjects, where infants will be assigned to receive either antibiotics or a placebo. The study focuses on clinically stable infants without known exposure to intraamniotic infection, assessing outcomes such as late-onset sepsis, necrotizing enterocolitis, and mortality. The trial employs rigorous randomization and blinding methods to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants with a gestational age of 23 to 30 weeks and 6 days who are clinically stable.
Not a fit: Patients who are at high risk for early-onset sepsis or have significant respiratory or hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for ELBW infants, potentially reducing adverse outcomes associated with antibiotic use.
How similar studies have performed: Previous studies have explored antibiotic use in neonates, but this specific approach of evaluating empiric antibiotics in stable ELBW infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
I. Inclusion criteria: We will enroll newborn infants with gestational age of 23-30 weeks 6 days infants at participating study sites will be eligible. II. Exclusion criteria: 1. Infants born for maternal indications via caesarean section with rupture of membranes at delivery, without attempts to induce labor, and without concern for maternal infection 2. Infants at high risk of EOS * Infants born to mothers with intrapartum fever (\> 38C) or clinical diagnosis of chorioamnionitis * Infants born to mothers with previous infant with GBS disease/infection 3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 \> 0.40 or non-invasive ventilation and FiO2 \> 0.60 at time of randomization 4. Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization 5. Clinician concern infant is at high risk for sepsis due to infant physical exam findings or clinical history of mother or infant 6. Major congenital anomalies 7. Infants not anticipated to survive beyond 72 hours 8. Infants who have received antibiotics prior to randomization 9. Mothers that are \<18 years old at time of enrollment
Where this trial is running
Mobile, Alabama and 17 other locations
- USA Children's and Women's Hospital — Mobile, Alabama, United States (RECRUITING)
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (RECRUITING)
- Yale University School of Medicine — New Haven, Connecticut, United States (RECRUITING)
- University of South Flordia Health — Tampa, Florida, United States (RECRUITING)
- University of Kansas Medical Center — Kansas City, Kansas, United States (WITHDRAWN)
- University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States (RECRUITING)
- Children's Mercy — Kansas City, Missouri, United States (WITHDRAWN)
- SUNY Downstate Medical Center — Brooklyn, New York, United States (WITHDRAWN)
- The Trustees of Columbia University in the City of New York — New York, New York, United States (RECRUITING)
- Golisano Children's Hospital at University of Rochester — Rochester, New York, United States (NOT_YET_RECRUITING)
- Maria Fareri Children's Hospital at Westchester Medical Center — Valhalla, New York, United States (RECRUITING)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (RECRUITING)
- Penn State Medical College — Hershey, Pennsylvania, United States (RECRUITING)
- Pennsylvania Hospital/The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
- Alfred I. duPont for Children of the Nemours Foundation — Philadelphia, Pennsylvania, United States (RECRUITING)
- Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)
- Mount Sinai Hospital — Toronto, Ontario, Canada (WITHDRAWN)
Study contacts
- Study coordinator: Michael J Morowitz, MD
- Email: michael.morowitz@chp.edu
- Phone: 412-692-5976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Death, Neonatal, premature birth