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Methadone Demonstration Project for NAS

NCT03134703Phase 2

Key facts

Status: Terminated
Start: Feb 2017
Primary completion: Mar 2019
Countries: 1
Sponsor: Johns Hopkins All Children's Hospital
Modality: Orthosteric Ligands

Drugs: methadone
Conditions: neonatal abstinence syndrome (NAS)

Overview

Phase 2, open-label trial of methadone in neonatal abstinence syndrome (NAS) (2 arms), sponsored by Johns Hopkins All Children's Hospital. Primary endpoint: Length of Stay at 25 days. Started Feb 2017; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Methadone Treatment Group
Methadone for NAS withdrawal
Comparison Group
Morphine (Standard of Care) for NAS withdrawal

Who it enrols

Newborns diagnosed with NAS, >= 37 weeks gestation, >= 2.5 kg birth weight, transferred within 72 hours. Mothers must be in Operation PAR program (for treatment group). Excludes major congenital anomalies or medical illness.

Endpoints

Primary

Length of Stay25 days

Secondary

Maternal Bonding Measured With The Postpartum Bonding Questionnaire6-8 weeks of age
Maternal Depression Measured With The Edinburgh Postnatal Depression Scale6-8 weeks of age
Readmission to HospitalWithin 30 days of discharge
Breast Milk30 days of age
Infant Development12 months
Screened vs. EligibleThrough completion
Attrition RateThrough completion
Home CareThrough completion

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