Who is sponsoring NCT02249026?

NCT02249026 is sponsored by Gauda, Estelle B., M.D..

What condition does NCT02249026 study?

NCT02249026 studies Drug; Withdrawal Symptoms, Neonatal, Withdrawal, Fetus and Newborn Affected by Other Maternal Medication.

What drugs are being tested in NCT02249026?

Interventions: BZDs + opiate exposure treated with BPN, Opiates exposure treated with BPN.

What is the status of NCT02249026?

NCT02249026 is currently UNKNOWN.

Last reviewed 2016-05-04 · How we verify

Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study

NCT02249026 Phase 1/Phase 2 UNKNOWN

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 infants born to mothers with co-dependence on an opiate and a benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in this population. If it is safe, we can include these infants in the large double blind, double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other hand, these infants have respiratory depression or other adverse events when buprenorphine is given, it will be important to report this study and caution the use of buprenorphine in these infants

Details

Lead sponsor	Gauda, Estelle B., M.D.
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	40
Start date	2014-10

Conditions

Drug; Withdrawal Symptoms, Neonatal
Withdrawal
Fetus and Newborn Affected by Other Maternal Medication

Interventions

BZDs + opiate exposure treated with BPN
Opiates exposure treated with BPN

Primary outcomes

Assessment of vital signs — 2-8 weeks
To determine the in infants with NAS who have in-utero exposure to opiates and BZDs. This is an un-blinded observational safety study. A total of 24 neonates with moderate to severe NAS will be enrolled at ACH and its obstetric affiliate Bayfront Hospital in Florida. 12 of these infants will have a positive screen (described below) for both maternally transferred opiate and BZD. The comparison group of 12 infants will have been exposed to opiates but not to BZDs during the pregnancy. Comparisons will be made both within and between groups. The principle outcome measures will be 1) respiratory function as measured by respiratory rate 2) a combined event score which includes episodes of apnea (\>20 sec apneic pause), bradycardia (\<80 bpm) and oxygen hemoglobin desaturation measured by pulse oximetry (\<90%). Other safety measures will include: blood pressures.

Countries

United States