Phase 4
N=17
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal · Neonatal Opioid Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04298853 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Enrollment Rate — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine PRN (Drug); Morphine scheduled (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
17 | — |
| PRIMARY Drop Out Rate |
4 | — |
| PRIMARY Number of Study Group Subjects Switched to Standard Arm |
— | — |
| SECONDARY Length of Hospital Stay From Birth to Discharge |
14.6; 11.6 | — |
| SECONDARY Total Cumulative Morphine Exposure |
3.6; 0.2 | — |
| SECONDARY Peak Morphine Dose |
0.09; 0.05 | — |
| SECONDARY Length of Morphine Treatment |
11.5; 2.9 | — |
Summary
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
Eligibility Criteria
Inclusion Criteria
- newborn greater than or equal to 35 weeks gestation
- intrauterine opioid exposure
- signs and symptoms of opioid withdrawal
Exclusion Criteria
- congenital anomalies or suspected genetic condition
- co-morbid conditions that require sedation or analgesia due to clinical condition
- ongoing need for respiratory support
Data sourced from ClinicalTrials.gov (NCT04298853). 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.