Microbial Colonization Clinical Trial
— NANOOfficial title:
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 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.
Status | Recruiting |
Enrollment | 802 |
Est. completion date | June 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Hours |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Penn State Medical College | Hershey | Pennsylvania |
United States | Children's Mercy | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky |
United States | USA Children's and Women's Hospital | Mobile | Alabama |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | The Trustees of Columbia University in the City of New York | New York | New York |
United States | Alfred I. duPont for Children of the Nemours Foundation | Philadelphia | Pennsylvania |
United States | Pennsylvania Hospital/The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | Golisano Children's Hospital at 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 Flordia Health | Tampa | Florida |
United States | Maria Fareri Children's Hospital at Westchester Medical Center | Valhalla | New York |
United States | Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Michael Morowitz | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbial diversity within infant fecal samples | Bacterial DNA will be sequenced according to established protocols. In analyses of these samples, we shall investigate three important parameters, namely, alpha diversity (Richness and Shannon Index), beta diversity, and the differential abundance of individual bacterial taxa. | Weekly stool samples will be collected for the first 8 weeks of life and then monthly through death or discharge from the subject's birth hospital , assessed up to 50 weeks. | |
Primary | Composite incidence of NEC, LOS, or death | 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 or more. Death is defined as death during the index hospitalization. | From the time and day of randomization through the subject's date of death from any cause or discharge from the birth hospital, whichever comes first, assessed up until 50 weeks. | |
Secondary | NEC | 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. | From the time and day of randomization through the subject's date of death from any cause or discharge from the birth hospital, whichever comes first, assessed up until 50 weeks. | |
Secondary | LOS | 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 or more. | From the time and day of randomization through the subject's date of death from any cause or discharge from the birth hospital, whichever comes first, assessed up until 50 weeks. | |
Secondary | Death | Death is defined as death during the index hospitalization. | From the time and day of randomization through the subject's date of death from any cause or discharge from the birth hospital, whichever comes first, assessed up until 50 weeks. |
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