Premature Birth Clinical Trial
Official 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.
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. ;
| 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 |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
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 | |
| Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
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 |
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 | |
| Completed |
NCT00271115 -
Kangaroo Holding and Maternal Stress
|
N/A |