DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Improving Outcomes in Neonatal Abstinence Syndrome

Information source: Tufts Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal

Intervention: Neonatal Morphine Solution (Drug); Methadone (Drug); Phenobarbital (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Tufts Medical Center

Official(s) and/or principal investigator(s):
Jonathan Davis, MD, Principal Investigator, Affiliation: Tufts Medical Center
Barry Lester, PhD, Principal Investigator, Affiliation: Women and Infant's Hospital

Overall contact:
Jonathan Davis, MD, Phone: 617-636-5322, Email: jdavis@tuftsmedicalcenter.org

Summary

1: SPECIFIC AIM I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants. 2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months. 3: SPECIFIC AIM III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.

Clinical Details

Official title: Improving Outcomes in Neonatal Abstinence Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Length of hospital stay

Secondary outcome:

Total opioid days

Maximum daily dose of replacement opioid

Mean Finnegan Score

Need for a second NAS medication

Detailed description: 1: SPECIFIC AIM I: To compare the short term efficacy of morphine and methadone for the treatment of NAS. One hundred eighty four term infants with a diagnosis of NAS requiring pharmacotherapy will be studied. Infants born to mothers receiving adequate prenatal care and maintained on opioid agonist medication during pregnancy will be eligible. Infants will be randomized to receive either neonatal morphine solution or methadone in a double blind, double dummy design. It is hypothesized that morphine treated infants will require significantly fewer days in the hospital compared to methadone treated infants. While the primary outcome is the total length of initial hospital stay (LOS), total LOS related to NAS, total duration of medical treatment for NAS, the need for a second drug to control symptoms, and infant growth will also be evaluated as important secondary outcomes by medication group assignment. 2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants in both treatment groups will be evaluated at 18 months of age using the Bayley III Scales of Infant Development. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes at 18 months compared to methadone treated infants. It is also hypothesized that neurobehavioral abnormalities (from either treatment group) identified at two weeks of age using the NICU Network Neurobehavioral Scale (NNNS) will correlate with neurodevelopmental impairment detected with the Bayley III. Early identification of infants at highest risk for impaired development will facilitate therapeutic interventions to improve outcome and decrease resource utilization. 3: SPECIFIC AIM III: To determine if single nucleotide polymorphisms (SNPs) in genes controlling opioid pharmacodynamics contribute to the severity of NAS. SNP genotyping from cord blood or buccal swabs will be obtained from all infants and correlated with short term outcomes (Aim 1) and neurodevelopment assessments (Aim 2) to confirm that genetic variation plays a major role in the severity and outcome of infants with NAS.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Mother receiving methadone or buprenorphine (BPH) from a licensed physician or drug treatment program, or an opioid prescribed by a licensed health care worker for treatment of chronic pain. 2. Need for treatment of NAS by Finnegan Scoring criteria 3. Gestational age >37 weeks at birth defined by best obstetrical estimate 4. Medically stable in the opinion of the Attending Physician 5. Mother receiving "adequate" or "intermediate" prenatal care from a qualified physician or midwife as defined by the Prenatal Care Adequacy Index 6. Singleton pregnancy 7. Mother able to provide informed consent 8. Infant able to take oral medications Exclusion criteria: 1. Gestation <37 weeks at entry defined by best obstetrical estimate 2. Major congenital abnormalities including genetic syndromes 3. Serious medical illness such as sepsis, asphyxia, seizures, or respiratory failure 4. Mother abusing alcohol during pregnancy (average of 3 or more drinks per week in the last 30 days) 5. Multiple gestations 6. Mother received "inadequate" prenatal care as defined by the Prenatal Care Adequacy Index.

Locations and Contacts

Jonathan Davis, MD, Phone: 617-636-5322, Email: jdavis@tuftsmedicalcenter.org

Shands Jacksonville Medical Center, Jacksonville, Florida 32209, United States; Recruiting
Mark Hudak, MD, Phone: 904-244-4242, Email: mark.hudak@jax.ufl.edu

Maine Medical Center, Portland, Maine, United States; Recruiting
Peter Marro, MD, Email: MARROP@mmc.org
Peter Marro, MD, Principal Investigator

Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Elisha Wachman, MD, Phone: 617-414-3690, Email: Elisha.Wachman@bmc.org
Michael Silverstein, MD, Principal Investigator
Elisha Wachman, MD, Sub-Investigator

Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Jonathan Davis, MD, Phone: 617-636-5322, Email: jdavis@tuftsmedicalcenter.org
Morgan R Newsome, DO, Phone: 617-636-2392, Email: mnewsome@tuftsmedicalcenter.org
Jonathan Davis, MD, Principal Investigator

Baystate Medical Center, Springfield, Massachusetts 01199, United States; Recruiting
Jeffrey Shenberger, MD, Phone: 413-794-5370, Email: jeffrey.shenberger@baystatehealth.org
Jeffrey Shenberger, MD, Principal Investigator

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Debra L Bogen, MD, Phone: 412-692-6932, Email: bogendl@upmc.edu
Debra L Bogen, MD, Principal Investigator

Women and Infant's Hospital of Rhode Island, Providence, Rhode Island 02908, United States; Recruiting
Barry Lester, PhD, Phone: 401-453-7640, Email: BLester@WIHRI.org
Barry Lester, PhD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Barbara Engelhardt, MD, Phone: 615-322-3475, Email: Barbara.Engerhardt@vanderbilt.edu
Barbara Engelhardt, MD, Principal Investigator

Additional Information

Related publications:

Wachman EM, Hayes MJ, Brown MS, Paul J, Harvey-Wilkes K, Terrin N, Huggins GS, Aranda JV, Davis JM. Association of OPRM1 and COMT single-nucleotide polymorphisms with hospital length of stay and treatment of neonatal abstinence syndrome. JAMA. 2013 May 1;309(17):1821-7. doi: 10.1001/jama.2013.3411.

Sarkar S, Donn SM. Management of neonatal abstinence syndrome in neonatal intensive care units: a national survey. J Perinatol. 2006 Jan 1;26(1):15-7.

Lainwala S, Brown ER, Weinschenk NP, Blackwell MT, Hagadorn JI. A retrospective study of length of hospital stay in infants treated for neonatal abstinence syndrome with methadone versus oral morphine preparations. Adv Neonatal Care. 2005 Oct;5(5):265-72.

Lötsch J, Skarke C, Liefhold J, Geisslinger G. Genetic predictors of the clinical response to opioid analgesics: clinical utility and future perspectives. Clin Pharmacokinet. 2004;43(14):983-1013. Review.

Jansson LM, Velez M, Harrow C. The opioid-exposed newborn: assessment and pharmacologic management. J Opioid Manag. 2009 Jan-Feb;5(1):47-55. Review.

Osborn DA, Jeffery HE, Cole MJ. Opiate treatment for opiate withdrawal in newborn infants. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD002059. doi: 10.1002/14651858.CD002059.pub3. Review.

Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.

Starting date: September 2013
Last updated: May 15, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017