Phase 4
Completed N=31
NAS Treatment - Opiate Versus Non-Opiate
Source: ClinicalTrials.gov NCT01734551 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Finnegan Neonatal Abstinence Scoring System — 7.5; 8.5; 6.6; 5.7 scores on a scale
◆ Published Evidence
Established
76citations · ~7 / year
Morphine versus clonidine for neonatal abstinence syndrome.
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.
Linked Publications (2)
-
Morphine versus clonidine for neonatal abstinence syndrome.
-
Opioid treatment for opioid withdrawal in newborn infants.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.