Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome

NCT03134703 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00107690
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• Length of Stay (LOS)

  Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.

  25 days

Secondary Outcomes (10)

• Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)

  inpatient and at 6-8 weeks of age

• Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)

  While inpatient and at 6-8 weeks of age

• Readmission to Hospital

  Within 30 days of discharge

• Breast Milk

  30 days of age

• Infant Development

  4, 8 and 12 months of age

Study Arms (2)

Methadone Treatment Group

EXPERIMENTAL

NAS infants treated for withdrawal symptoms with methadone

Drug: Methadone

Comparison Group

ACTIVE COMPARATOR

NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)

Drug: Morphine

Interventions

Methadone DRUG

Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)

Methadone Treatment Group

Morphine DRUG

Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)

Comparison Group

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Baby is diagnosed with neonatal abstinence syndrome;
• Mother under the care of Operation PAR;
• Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
• Mother has been deemed by PAR officials as being compliant with the detoxification program;
• Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
• Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
• No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
• Newborns ≥ 37 0/7 weeks gestation;
• Newborns transferred to JHACH within 72 hours from birth;
• Newborns ≥ 2.5 kg weight at birth;
• Informed parental consent.

You may not qualify if:

• Major congenital anomalies;
• Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
• Infants who are being placed for adoption;
• Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
• Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
• Mother with hearing or language impairment
• Comparison Group:
• Baby is diagnosed with neonatal abstinence syndrome;
• Newborns ≥ 37 0/7 weeks gestation;
• Newborns transferred to JHACH within 72 hours from birth;
• Newborns ≥ 2.5 kg weight at birth;
• Informed parental consent.
• Infant not requiring pharmacologic treatment for NAS;
• Major congenital anomalies;
• Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead
• Florida Department of Health: collaborator

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Sandra Brooks, MD
• Organization: Johns Hopkins All Children's Hospital

sbrook36@jhmi.edu

727-767-4313

Study Officials

• Sandra Brooks, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: May 1, 2017
• Study Start: February 27, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 27, 2019
• Last Updated: July 3, 2023
• Results First Posted: May 19, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)