Active — Not RecruitingPhase 4

Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

United States69 participantsStarted 2018-02-21

Plain-language summary

The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .

Who can participate

Age range10 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Born at Cooper University Hospital * Greater than or equal to 35 weeks gestation age * Admitted to the NICU or Transitional nursery * Mothers admitted to using illicit substances or prescription medications (which can result in withdrawal symptoms) while pregnant and/or had a positive urine drug screen during pregnancy. * Babies being started on medication to control withdrawal symptoms of NAS. * No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.) Exclusion Criteria: * Premature infants \<35 week gestational age * Infants with major congenital abnormalities * Blood pressure instability * Major medical conditions

What they're measuring

Length of treatment

Timeframe: From initiation of medical treatment through last dose of medication given, up to 100 days

Trial details

NCT IDNCT03092011

SponsorThe Cooper Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials