Premature Birth Clinical Trial
— NANO-FUOfficial title:
NICU Antibiotics and Outcomes Follow-Up Study
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 neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.
Status | Not yet recruiting |
Enrollment | 802 |
Est. completion date | March 2029 |
Est. primary completion date | March 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Weeks to 30 Weeks |
Eligibility | 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: 1. 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 2. Infants at high risk for early onset sepsis- Infants born to mothers with intrapartum fever (> 38ÂșC) 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Sinai Health System | Toronto | |
United States | State University of New York Downstate | Brooklyn | New York |
United States | The Pennsylvania State University | Hershey | Pennsylvania |
United States | University of Louisville | Louisville | Kentucky |
United States | Yale University | New Haven | Connecticut |
United States | Columbia University | New York | New York |
United States | Jefferson Medical College of Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Magee-Womens Hospital | Pittsburgh | Pennsylvania |
United States | The University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | University of Rochester | Rochester | New York |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Sharp Mary Birch Hospital for Women & Newborns | San Diego | California |
United States | University of South Florida | Tampa | Florida |
United States | Westchester Medical Center | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Sharp HealthCare | Children's Hospital of Philadelphia, Jefferson Medical College of Thomas Jefferson University, Morgan Stanley Children's Hospital, Mount Sinai Hospital, Canada, Penn State University, Sharp Mary Birch Hospital for Women & Newborns, State University of New York - Downstate Medical Center, The University of Texas Health Science Center at San Antonio, University of Louisville, University of Pittsburgh, University of South Florida, Westchester Medical Center, Yale University |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of neurodevelopmental impairment or Death | The first primary outcome will be a composite of newborn or childhood death OR one of following: cognitive or motor composite scores <80 on the Bayley-4, Gross Motor Function Classification Score score =2, bilateral blindness, severe functional hearing impairment. The incidence of the composite outcome will be compared between the placebo and early antibiotic groups. | 24 months corrected gestational age | |
Primary | DOOR probability Distribution | The second primary outcome will be a comparison of the DOOR probability of more desirable outcomes at 2 years using a novel ordinal endpoint scale developed during the trial. Outcomes to be included in the rank are as follows: death, cognitive/language/motor composite scores<80 on the Bayley-4, Gross Motor Function Classification Score =2, bilateral blindness, severe functional hearing impairment, Child Behavior Checklist (CBCL) scores >70, autism risk scores (MCHAT R/F) of =2, and medical measures, such as need for oxygen support. The distribution of the finalized neoDOOR will be compared between the placebo and empiric antibiotic groups. | 24 months corrected gestational age |
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