Phase 4
N=28
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02851303 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Length of Hospital Stay — 17.9; 16.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Methadone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay |
17.9; 16.1 | — |
| SECONDARY Length of Treatment |
14.7; 12.8 | — |
| SECONDARY Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital) |
1; 0 | — |
| SECONDARY Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition. |
11; 6 | — |
| SECONDARY Need for NICU Transfer, as Determined by Chart Review of Discharge Summary. |
0; 3 | — |
| SECONDARY Breastfeeding Initiation and Continuation at Hospital Discharge |
5; 5 | — |
| SECONDARY Total Morphine Equivalent Dose Received |
9.86; 33.0 | — |
Summary
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.
Eligibility Criteria
Inclusion criteria
- Born at University of New Mexico Hospital
- Greater than 34 weeks gestation
- Primary in-utero drug exposure was opioids other than buprenorphine
- Maternal or infant urine drug screen positive for methadone and/or opioids on admission
Exclusion criteria
- Born prior to 34 weeks
- Neonatal intensive care unit admission
- Serious medical comorbidities
- Primary substance exposure in-utero was buprenorphine, or was not opioids
Data sourced from ClinicalTrials.gov (NCT02851303). 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.