Phase 3
Completed N=117
Improving Outcomes in Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal
Source: ClinicalTrials.gov NCT01958476 ↗
Enrolled (actual)
117
Serious AEs
6.9%
Results posted
Oct 2019
Primary outcomePrimary: Length of Hospital Stay (LOS) — 21.8; 23.2 days
◆ Published Evidence
Highly cited
▲ Trending
101citations · ~13 / year
Comparison of Safety and Efficacy of Methadone vs Morphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Clinical Trial.
Summary
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants.
2. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months.
3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.
Linked Publications (3)
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Comparison of Safety and Efficacy of Methadone vs Morphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Clinical Trial.
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Neurodevelopmental Outcomes of Neonates Randomized to Morphine or Methadone for Treatment of Neonatal Abstinence Syndrome.
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Opioid treatment for opioid withdrawal in newborn infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay (LOS) |
21.8; 23.2 | — |
| SECONDARY Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) |
18.9; 21.1 | — |
| SECONDARY Length of Treatment (LOT) |
14.7; 16.6 | — |
| SECONDARY Maximum Daily Dose of Replacement Opioid |
— | — |
| SECONDARY Mean Finnegan Score (FS) |
— | — |
| SECONDARY Number of Infants Needing a Second NAS Medication |
10; 17 | — |
| SECONDARY Growth Outcome: Weight Change From Birth to 18 Months |
19.1; 18.7 | — |
| SECONDARY Growth Outcome: Head Circumference at 18 Months |
47.8; 48.2 | — |
| SECONDARY Maximum Finnegan Score |
— | — |
| SECONDARY Growth Outcome: Length at 18 Months |
82.1; 81.7 | — |
Eligibility Criteria
Inclusion criteria
- Mother receiving methadone or buprenorphine (BPH) from a licensed physician or drug treatment program, or an opioid prescribed by a licensed health care worker for treatment of chronic pain.
- Need for treatment of NAS by Finnegan Scoring criteria
- Gestational age >37 weeks at birth defined by best obstetrical estimate
- Medically stable in the opinion of the Attending Physician
- Mother receiving "adequate" or "intermediate" prenatal care from a qualified physician or midwife as defined by the Prenatal Care Adequacy Index
- Singleton pregnancy
- Mother able to provide informed consent
- Infant able to take oral medications
Exclusion criteria
- Gestation <37 weeks at entry defined by best obstetrical estimate
- Major congenital abnormalities including genetic syndromes
- Serious medical illness such as sepsis, asphyxia, seizures, or respiratory failure
- Mother abusing alcohol during pregnancy (average of 3 or more drinks per week in the last 30 days)
- Multiple gestations
- Mother received "inadequate" prenatal care as defined by the Prenatal Care Adequacy Index.
Data sourced from ClinicalTrials.gov (NCT01958476) 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.