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

NCT ID: NCT03134703

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2019-03-27

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.

Detailed Description

For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have been cared for in the JHACH NICU with an average length of stay of 30 days. Such a prolonged length of stay has a negative impact on maternal/infant bonding. In addition, infants suffering from NAS have poor regulatory mechanisms and are invariably hard to care for and difficult to console, and they provide an emotional challenge to their caretakers. This challenge becomes even more significant when the caretaker is the mother who is suffering from addiction and is already emotionally compromised by feelings of depression, anxiety, guilt or insecurity. Attachment is an ongoing process and the quality of the relationship between mother and her infant directly influences the structure of the child's affective ties and overall organization of responses to environment. This mother-infant bond sets the stage for understanding and identifying the infant's needs and reciprocal parental response to those needs. Maternal emotional unavailability has potentially serious effects on the long term mother-child relationship, and on the child's development.

This project provides a novel approach and an alternative care plan for infants with NAS. It is funded by the State of Florida and allows to: 1) educate and empower a specified population of mothers who are undergoing institutionalized rehabilitation and whose infant needs treatment for NAS; 2) safely transition the infants home for final wean of their pharmacologic treatment; 3) provide regular developmental follow up for these infants through our NICU follow up clinic, hence identifying and quickly responding to neuro-developmental delays.

Conditions

Neonatal Abstinence Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methadone Treatment Group

NAS infants treated for withdrawal symptoms with methadone

Group Type: EXPERIMENTAL

Methadone

Intervention Type: 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)

Comparison Group

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

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Interventions

Methadone

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Baby is diagnosed with neonatal abstinence syndrome;

2. Mother under the care of Operation PAR;

3. Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;

4. Mother has been deemed by PAR officials as being compliant with the detoxification program;

5. Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;

6. Mother has been prescreened and deemed adequate candidate by the demonstration project team members;

7. No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;

8. Newborns ≥ 37 0/7 weeks gestation;

9. Newborns transferred to JHACH within 72 hours from birth;

10. Newborns ≥ 2.5 kg weight at birth;

11. Informed parental consent.

1. Baby is diagnosed with neonatal abstinence syndrome;

2. Newborns ≥ 37 0/7 weeks gestation;

3. Newborns transferred to JHACH within 72 hours from birth;

4. Newborns ≥ 2.5 kg weight at birth;

5. Informed parental consent.

Exclusion Criteria

1. Major congenital anomalies;

2. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;

3. Infants who are being placed for adoption;

4. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);

5. Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.

6. Mother with hearing or language impairment

Comparison Group:

1. Infant not requiring pharmacologic treatment for NAS;

2. Major congenital anomalies;

3. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;

4. Infants who are being placed for adoption;

5. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);

6. Mother with hearing or language impairment;

7. Infants known upon admission who will be placed into state custody or sheltered.

• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Department of Health

OTHER_GOV

Sponsor Role: collaborator

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Brooks, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00107690

Identifier Type: -

Identifier Source: org_study_id