Phase 4
Completed N=17
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal · Neonatal Opioid Withdrawal Syndrome
Source: ClinicalTrials.gov NCT04298853 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Enrollment Rate — 17 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.