Clinical Trial: Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief Summary: This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.
Detailed Summary:
Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known as neonatal abstinence syndrome (NAS). Infants with NAS are at risk for multiple medical complications including failure to thrive and seizures, they often require prolonged hospital stays and account for significant health care costs. At University of New Mexico, infants exposed to methadone or heroin in utero who develop NAS requiring pharmacologic treatment undergo a treatment wean with methadone, whereas infants exposed to buprenorphine undergo a wean with morphine. However, morphine is used frequently to treat neonatal abstinence syndrome among methadone-exposed infants throughout the US, and optimal pharmacologic treatment for NAS remains unknown. Anecdotal evidence at the investigators institution suggests that infants treated with morphine have shorter hospital stays compared to infants treated with methadone. Investigators propose a pilot randomized controlled trial to evaluate morphine vs methadone treatment of infants with in-utero methadone or heroin exposure. Specifically, length of treatment, need for additional medication to treat withdrawal, and length of hospital stay will be compared.
When women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research staff will approach patients about study enrollment. Participants will be approached for study enrollment if medication list on admission includes methadone, if participants self-report methadone use prenatally, and/ or if urine drug screen is positive for methadone or opiates on admission. If women choose to enroll in the study, and their infants require treatment for NAS, their infants will be randomized and assigned a study number for treatment using the methadone or morphine protocols at the time treatment is required.
All infants will be mo
Sponsor: University of New Mexico
Current Primary Outcome: Length of hospital stay [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of treatment [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Patient satisfaction by HCAHPS Patient Satisfaction Survey Tool [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Need for additional agent to treat withdrawal, determined by chart review of Medication Administration Record of administered medications for withdrawal treatment (example: clonidine or phenobarbital) [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Need for feeding assistance, determined by chart review of discharge summary, specifically evaluating for need for nasogastric tube placement or peripheral parenteral nutrition. [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Need for NICU transfer, as determined by chart review of discharge summary. [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Infant weight change [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
- Breastfeeding initiation and continuation at hospital discharge [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]Assessed through chart review of discharge summary documentation of method of infant feeding at time of discharge
- Total morphine equivalent dose received [ Time Frame: assessed at hospital discharge, approximately 7-30 days ]
Original Secondary Outcome: Same as current
Information By: University of New Mexico
Dates:
Date Received: July 19, 2016
Date Started: October 2016
Date Completion: January 2018
Last Updated: July 27, 2016
Last Verified: July 2016
