Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
802 participants
INTERVENTIONAL
2024-04-30
2029-03-31
Brief Summary
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Detailed Description
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The proposed NANO follow-up study will build upon the parent NANO trial to determine whether avoiding antibiotics in very preterm infants - a simple, cost-effective intervention - improves neurodevelopmental and behavioral outcomes during the toddler years. Evaluation of children enrolled in the proposed NANO follow-up study will include serial comprehensive, standardized assessments of motor, cognitive, behavioral and adaptive outcomes. To support retention and provide an important early assessment, a first virtual visit at 1 year of age will include the Hammersmith Infant Neurologic Exam (HINE) and the Developmental Assessment of Young Children, Second Edition (DAYC-2). A second comprehensive follow-up visit in person at 2 years will include the Bayley Scales of Infant Development 4th ed., Gross Motor Function Classification System, Child Behavior Checklist for ages 1.5-5, and the Modified Checklist for Autism in Toddlers, Revised, with Follow-up.
In the NANO follow-up trial, outcomes will be assessed using the Desirability of outcome ranking (DOOR), an innovative, patient-centered statistical approach used in clinical trials to evaluate the global benefits and risks of an intervention. The ordinal neonatal follow-up endpoint composite scale, to be named neoDOOR, will be developed by both clinicians and families. Stakeholder meetings will develop consensus rankings of individual and composite outcomes of different severities reported by the above developmental assessments. Neonatal biospecimens collected during the parent NANO trial will allow for additional exploratory analyses evaluating interactions among genetics, environment, and microbiota with antibiotic exposure and long-term outcomes. Through these assessments and evaluation, the investigators will provide substantial evidence for the use (or non-use) of early antibiotics for very preterm infants at birth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of empiric antibiotic treatment.
Ampicillin
Intravenous Ampicillin
Gentamicin
Intravenous Gentamicin
Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.
Placebo
Intravenous Normal Saline
Interventions
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Ampicillin
Intravenous Ampicillin
Gentamicin
Intravenous Gentamicin
Placebo
Intravenous Normal Saline
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. 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
3. 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
4. Infants with ongoing hemodynamic instability requiring vasopressors or more than one fluid bolus at time of randomization
5. Clinician concern for sepsis due to 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.
23 Weeks
30 Weeks
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Morgan Stanley Children's Hospital
OTHER
University of Louisville
OTHER
Sharp Mary Birch Hospital for Women & Newborns
OTHER
Children's Hospital of Philadelphia
OTHER
Jefferson Medical College of Thomas Jefferson University
OTHER
University of South Florida
OTHER
Westchester Medical Center
OTHER
Yale University
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
Penn State University
OTHER
State University of New York - Downstate Medical Center
OTHER
Mount Sinai Hospital, Canada
OTHER
Sharp HealthCare
OTHER
Responsible Party
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Anup Katheria, M.D.
PI
Principal Investigators
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Anup Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
Locations
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Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
University of Louisville
Louisville, Kentucky, United States
State University of New York Downstate
Brooklyn, New York, United States
Columbia University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Westchester Medical Center
Valhalla, New York, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
The University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Sinai Health System
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NANO Follow-Up
Identifier Type: -
Identifier Source: org_study_id
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