Status:
NOT_YET_RECRUITING
NICU Antibiotics and Outcomes (NANO) Follow-up Study
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
University of Pittsburgh
Morgan Stanley Children's Hospital
Conditions:
Premature Birth
Antibiotics
Eligibility:
All Genders
23-30 years
Phase:
PHASE3
Brief Summary
The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurologi...
Detailed Description
The multidisciplinary team launched the NANO (NICU Antibiotics and Outcomes) Trial to study the longstanding clinical practice of empirically administering intravenous antibiotics to very preterm infa...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Families that have agreed to participate and are enrolled in the parent NANO trial will be eligible for the NANO follow-up study. There will be no exclusions for eligible children entering the follow-up study.
- Parent NANO trial Criteria:
- I. Inclusion criteria: We will enroll newborn infants with gestational age of 23.0-30.6 weeks born to mothers 18 years or older at participating study sites. Only inborn infants at participating study sites will be eligible.
- II. Exclusion criteria:
- Infants at low risk for early onset sepsis-Infants born for maternal indications via caesarean section with rupture of membranes within 6 hours, without attempts to induce labor, and without concern for maternal infection
- Infants at high risk for early onset sepsis- Infants born to mothers with intrapartum fever (\> 38ºC) or clinical diagnosis of chorioamnionitis (suspected or definite), infants born to mothers with proven Group B Streptococcus colonization or indication for intrapartum antibiotic prophylaxis that did not receive adequate antibiotic treatment according to specialty specific guidelines, (i.e., penicillin, ampicillin, cefazolin), infant born to mother with previous infant with GBS disease/infection
- Infants with respiratory insufficiency requiring invasive mechanical ventilation and fraction of inspired oxygen\> 0.40 or non-invasive ventilation and fraction of inspired oxygen \> 0.60 at time of randomization
- Infants with ongoing hemodynamic instability requiring vasopressors or more than one fluid bolus at time of randomization
- Clinician concern for sepsis due to physical exam findings or clinical history of mother or infant
- Major congenital anomalies
- Infants not anticipated to survive beyond 72 hours
- Infants who have received antibiotics prior to randomization.
Exclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT05977400
Start Date
April 1 2024
End Date
March 1 2029
Last Update
August 4 2023
Active Locations (15)
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1
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
2
Yale University
New Haven, Connecticut, United States, 06511
3
University of South Florida
Tampa, Florida, United States, 33620
4
University of Louisville
Louisville, Kentucky, United States, 40292