Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05977400
Other study ID # NANO Follow-Up
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 2024
Est. completion date March 2029

Study information

Verified date July 2023
Source Sharp HealthCare
Contact Anup Katheria, MD
Phone 8589394170
Email anup.katheria@sharp.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 infants. The NANO trial is an 802-patient,13-site randomized blinded controlled trial (R01HD09757801) discerning whether administration of antibiotics within the first three days of life increases the incidence of short-term, life-threatening complications among very preterm infants. 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ampicillin
Intravenous Ampicillin
Gentamicin
Intravenous Gentamicin
Placebo
Intravenous Normal Saline

Locations

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

Sponsors (14)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Active, not recruiting NCT03655639 - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT03337659 - A Cluster Randomized Controlled Trial of FICare at 18 Months N/A
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Completed NCT03251729 - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix Phase 4
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT02880696 - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates N/A
Completed NCT02913495 - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Phase 4
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT02743572 - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants N/A
Completed NCT02879799 - Family Integrated Care (FICare) in Level II NICUs N/A
Completed NCT02661360 - Effects of Swaddling on Infants During Feeding N/A
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Terminated NCT00675753 - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families N/A
Terminated NCT00179972 - Evaluation of Pulse Oximetry Sensors in Neonates N/A