Methadone Demonstration Project With Neonatal Intensive Care Unit Infants

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03134703
Study type	Interventional
Source	Johns Hopkins All Children's Hospital
Contact
Status	Terminated
Phase	Phase 2
Start date	February 27, 2017
Completion date	March 27, 2019

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See also
Status	Clinical Trial	Phase
Completed	`NCT01965704` - Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women	Phase 2
Completed	`NCT03890562` - Assessing the Effects of Auricular Acupressure on Newborns With NAS	N/A
Completed	`NCT01958476` - Improving Outcomes in Neonatal Abstinence Syndrome	Phase 3
Active, not recruiting	`NCT01734551` - NAS Treatment - Opiate Versus Non-Opiate	Phase 4
Completed	`NCT00496951` - Vagal Tone and Neonatal Abstinence Syndrome	N/A
Completed	`NCT02851303` - Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome	Phase 4
Recruiting	`NCT05226624` - The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program	N/A
Completed	`NCT03670160` - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome	Phase 2
Not yet recruiting	`NCT04611659` - Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine	N/A
Completed	`NCT01452789` - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome	Phase 3
Completed	`NCT04588519` - tAN to Mitigate Withdrawal Behaviors in Neonates	N/A
Completed	`NCT02797990` - Conflict Between Maternal Autonomy and Child Health in Substance-use	N/A
Completed	`NCT02801331` - Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome	N/A
Terminated	`NCT03246243` - Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Completed	`NCT03567603` - Sound Processing Changes in Babies With Opioid Exposure
Recruiting	`NCT06303986` - Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Active, not recruiting	`NCT03725332` - The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky	N/A
Recruiting	`NCT04983563` - Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units	N/A
Completed	`NCT04298853` - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome	Phase 4
Completed	`NCT02182973` - Donor Human Milk in Neonatal Abstinence Syndrome

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms