Status:
UNKNOWN
Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study
Lead Sponsor:
Gauda, Estelle B., M.D.
Collaborating Sponsors:
Johns Hopkins University
Johns Hopkins All Children's Hospital
Conditions:
Drug; Withdrawal Symptoms, Neonatal
Withdrawal
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE1
PHASE2
Brief Summary
Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic treatment; those i...
Detailed Description
The Problem: Infants who are born to mothers taking or abusing opiates frequently suffer from neonatal abstinence syndrome (NAS) after birth. They often have withdrawal symptoms which can be life thre...
Eligibility Criteria
Inclusion
- Newborns ≥ 35 0/7 wks. Gestation undelivered or \< 12 hours of age at enrollment and within the 72 hrs. after birth at the time of transfer to ACH for pharmacologic treatment for moderate to severe NAS
- Newborns ≥ 2 kg weight at birth (10th % for a 35 0/7 wk. newborn)
- Informed parental
Exclusion
- Newborns \<35 0/7 wks. gestation OR older than 72 hrs. of life at time of transfer to ACH for pharmacologic treatment for moderate to severe NAS
- Major congenital anomalies
- Major concomitant medical illness including antibiotic treatment for greater than 3 days
- Any illness that precludes oral or sublingual medication use
- Infants who have received any drug other than "study drug" to treat their NAS
- Infants requiring drug therapy with any high or moderate CYP3A4 inhibitor or inducer (Appendix A)
- Breastfeeding infants.
- Infants in significant pain requiring medication for comfort (for example those with a fracture).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02249026
Start Date
October 1 2014
Last Update
May 6 2016
Active Locations (1)
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1
All Children's Hopsital
St. Petersburg, Florida, United States, 33701