Phase 4
N=31
NAS Treatment - Opiate Versus Non-Opiate
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01734551 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Finnegan Neonatal Abstinence Scoring System — 7.5; 8.5; 6.6; 5.7 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Clonidine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Henrietta Bada
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Finnegan Neonatal Abstinence Scoring System |
7.5; 8.5; 6.6; 5.7; 7.1; 6.7 | — |
| PRIMARY Duration of Treatment |
39; 27 | — |
| SECONDARY Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) |
5.06; 4.51; 0.36; 0.42; 4.77; 4.92 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development Third Edition |
97.6; 95.8; 92.9; 93.3; 98.0; 95.8 | — |
Summary
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.
Eligibility Criteria
Inclusion Criteria
- Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks
- Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
- Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment
Exclusion Criteria
- Seizures
- Major congenital malformations
- Unlikely to survive
- Parents not able to understand English
Data sourced from ClinicalTrials.gov (NCT01734551). 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.