- Women who use opioid drugs during pregnancy could increase the risk of withdrawal symptoms in babies.
- Infants are treated with opioid drugs initially to wean off the withdrawal symptoms.
- Buprenorphine treatment has been found to reduce opioid withdrawal symptoms in infants by 47%
Babies born to women who use opioid drugs during pregnancy are at a risk of suffering from withdrawal symptoms. Neonatal Abstinence Syndrome (NAS) refers to a group of symptoms that can cause serious problems in the infant when the expecting mother takes opioids.
In order to reduce the severity of the symptoms, infants are treated with opioids and then slowly weaned off after a month. However, a new research study from the Thomas Jefferson University showed a more effective treatment with Buprenorphine that can safely cut down the therapy to nearly half in patients.
Walter Kraft, M.D., Professor and Director, Clinical Research Unit in the Department of Pharmacology and Experimental Therapeutics in the Sidney Kimmel Medical College at Thomas Jefferson University, said, "This is a practice-changing advance for treatment of babies with NAS."
Currently, morphine has been used for treating infants who experience withdrawal symptoms. But, evidence that supports morphine use was found to be lacking.
Kraft said, "Testing therapeutics in infants has always been challenging. Families are understandably apprehensive about entering their infants into clinical trials."
"But it is essential that we study whether these therapies are effective, because infants are not simply smaller versions of adults. Their physiology is unique and we need to continue to build evidence for their treatment. Improving care based on solid evidence was at the heart of this study."
The clinical trials were conducted on 63 infants who were divided into two treatment groups between October 2011 and May 2016. Infants with withdrawal symptoms were treated blindly with either morphine or buprenorphine.
The healthcare providers nor the families did not know which treatment was given after all the data was collected.
The study findings found that in around 30 infants who were treated with morphine drug required the therapy for about 28 days to control the withdrawal symptoms.
While, in the 33 infants allocated to buprenorphine alone required an average of 15 days. The treatment time has been reduced by about 47%
Kraft said, "We suspect that buprenorphine is more effective because it works a little differently at the opioid receptor. It is also a longer lasting drug than morphine, requiring a dose every eight hours rather than the four required for morphine."
Buprenorphine drug was found to be safe as morphine in the trial. Even though the drug has not been tested in the study, buprenorphine treatment in infants could be effective.
Michelle E.Ehrlich, M.D., from the Icahn School of Medicine at Mount Sinai said, "The beauty of our results is that the drug is immediately readily available, unequivocally effective, non-invasive and safe. This could impact standard of care for and the financial cost of neonatal abstinence syndrome."
"In future studies, Dr. Kraft and I hope to research how genetics may inform and influence an infant's response to medication."
Mothers who had a history of substance abuse were found to enrol their infants in the study and were treated with counseling, medication and group therapy at Maternal Addiction Treatment Education and Research (MATER) Program at Jefferson.
Dr. Kraft said, "Jefferson has led the charge on treating neonatal abstinence syndrome since the 1970s."
"Research within this population is challenging and the strength of the results speaks to the clinical staff who worked with the families and helped them feel fully supported by our team, in a way that was non-judgmental. This partnership was essential to finding such meaningful results."
- Walter K. Kraft et al, Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome, New England Journal of Medicine (2017) DOI: 10.1056/NEJMoa1614835