Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01708707
First received: April 25, 2012
Last updated: September 5, 2013
Last verified: September 2013

April 25, 2012
September 5, 2013
December 2012
December 2014   (final data collection date for primary outcome measure)
Hospital length of stay [ Time Frame: Up to hospital discharge, an anticipated average of 4 weeks ] [ Designated as safety issue: No ]
Number of days of hospital admission
Same as current
Complete list of historical versions of study NCT01708707 on ClinicalTrials.gov Archive Site
  • Number of adverse or serious adverse events [ Time Frame: Up to hospital discharge, with length of stay currently averaging approximately 4 weeks ] [ Designated as safety issue: Yes ]
  • Cost efficiency of buprenorphine [ Time Frame: At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks ] [ Designated as safety issue: No ]
    Cost of buprenorphine as a product of number of days of administration
  • Withdrawal symptoms [ Time Frame: Up to hospital discharge, usually occuring on average 4 weeks ] [ Designated as safety issue: No ]
    Finnegan methodology to score withdrawal symptoms every four hours of medication administration
  • Rescue dosage administration [ Time Frame: Up to hospital discharge, anticipating an average of 4 weeks ] [ Designated as safety issue: No ]
    Number of rescue doses of additional medication
Same as current
Not Provided
Not Provided
 
Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)

The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).

Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of stay and decrease number of days of drug treatment currently required in treatment of NAS. Another goal will be to understand buprenorphine as a cost effective treatment for NAS.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neonatal Abstinence Syndrome
  • Neonatal Withdrawal Syndrome
  • Drug: Buprenorphine

    The injectable formulation of buprenorphine (Buprenex; Reckitt Benckiser) will be prepared to a final concentration of 0.075 mg/mL in 100% ethanol and simple syrup USP to create a sublingual preparation.

    Infants initial dose: 15.9 µg/kg per day in 3 divided doses with escalation/weaning based upon standardized scoring of NAS symptoms, using standardized Finnegan scoring Maximum dosage: 60 µg/kg per day Duration: Infants will receive buprenorphine until they are successfully weaned off of opioids and no longer show withdrawal symptoms, evidenced by low Finnegan scores. Mean use in other investigations was 24 days.

    Other Names:
    • Sublingual buprenorphine
    • Other Name: Buprenex (buprenorphine)
    • NDC Number: 12496-0757-1
    • Product Code: 12496-0757
  • Drug: Morphine Sulfate
    Oral Morphine Sulfate Dosage: Morphine Sulfate Oral Solution 100mg/5mL Initially dosed at 0.4mg/kg per day in six daily doses Duration of medication administration dependent upon infant symptoms of neonatal withdrawal, with mean duration of use at Banner Good Samaritan Hospital currently averaging 25 days.
    Other Names:
    • Oral Morphine Sulfate
    • Morphine
    • NDC: 0406-8003-24
  • Active Comparator: Oral morphine sulfate
    Oral morphine sulfate 0.4 mg/kg/day morphine every 3-4 hours as needed for Finnegan scores suggestive of Neonatal Abstinence Syndrome Other Name: morphine
    Intervention: Drug: Morphine Sulfate
  • Experimental: Buprenorphine
    Sublingual Buprenorphine 15.9 µg/kg per day in 3 divided doses, titrated up or escalated down based upon standardized scoring for neonatal abstinence syndrome
    Intervention: Drug: Buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
64
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants of corrected gestational age ≥37 weeks
  • Chronic opioid exposure in utero
  • Signs and symptoms of NAS requiring treatment
  • 2 consecutive Finnegan scores ≥8 or any single score ≥12

Exclusion Criteria:

  • Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment
  • Life-threatening congenital malformations
  • Intrauterine growth retardation
  • Seizure activity or congenital neurologic abnormalities
  • Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment
  • Inability of mother's consent due to altered mental status or comorbid psychiatric disorder
  • Neonatal administration of morphine prior to enrollment into study
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01708707
Banner IRB 01-13-0030
Yes
Pediatrix Medical Group
Pediatrix Medical Group
Not Provided
Principal Investigator: Gregory Martin, MD Banner Good Samaritan Medical Center
Pediatrix Medical Group
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP