Phase 3
N=120
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03396588 ↗Enrolled (actual)
120
Serious AEs
20.0%
Results posted
May 2025
Primary outcome: Primary: Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) — 0.5; 0.3; 1.0; 0.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clonidine (Drug); Morphine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Henrietta Bada
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) |
0.5; 0.3; 1.0; 0.6; -0.1; 0.1 | — |
| PRIMARY Bayley Scales of Infant and Toddler Development Third Edition |
84.3; 81.1; 95.4; 86.2; 97.6; 96.0 | — |
| PRIMARY Bayley Scales of Infant and Toddler Development Third Edition |
84.3; 81.1; 95.4; 86.2; 97.6; 96.0 | — |
| PRIMARY Bayley Scales of Infant and Toddler Development Third Edition |
84.3; 81.1; 95.4; 86.2; 97.6; 96.0 | — |
| PRIMARY Ages and Stages Questionnaire Third Edition (ASQ-3) |
8; 8; 2; 2; 4; 1 | — |
| PRIMARY Ages and Stages Questionnaire Third Edition (ASQ-3) |
8; 8; 2; 2; 4; 1 | — |
| PRIMARY Childhood Behavior Checklist (CBCL) T-Scores |
52.31; 50.9; 54.8; 53.5; 53.6; 53.5 | — |
| SECONDARY Duration of Treatment |
17; 15 | — |
| SECONDARY Childhood Behavior Checklist 1.5-5 T-Scores |
5; 2; 1; 8; 2; 2 | — |
Summary
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.
Eligibility Criteria
Inclusion Criteria
- Gestational age (GA) > or equal to 35 weeks
- Known prenatal opiate exposure (by mother admitting use, mom with positive opiate screen during pregnancy, or positive neonatal urine and meconium screening)
- No known prenatal cocaine exposure
- No morphine or clonidine dose before enrollment
- Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to 8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision to treat for NAS
- Less than or equal to 7 days of age
- Attending physician decides to start pharmacologic treatment and agrees to infant's study participation
Exclusion Criteria
- Seizures
- Major congenital malformations
- Blood pressure instability
- Major medical condition in addition to NAS
- Parents unable to understand English
Data sourced from ClinicalTrials.gov (NCT03396588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.