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

NCT03092011 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 16-144
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• Length of treatment

  Duration of treatment of Neonatal Abstinence Syndrome with medication/pharmacological treatment from first day initiated until medication has been stopped or patient discharged home

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

Secondary Outcomes (1)

• Length of stay

  From birth through discharge from the hospital, up to 100 days.

Other Outcomes (2)

• Cognitive development

  From 6 months to 2 years corrected gestation.

• Cognitive development

  At 18-24 months corrected gestational age

Study Arms (2)

Clonidine

EXPERIMENTAL

Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours

Drug: Clonidine

Morphine

ACTIVE COMPARATOR

Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours

Drug: Morphine Sulfate

Interventions

Clonidine DRUG

Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours Clonidine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

Clonidine

Morphine Sulfate DRUG

Morphine at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours Morphine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

Also known as: Morphine

Morphine

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• Premature infants \<35 week gestational age
• Infants with major congenital abnormalities
• Blood pressure instability
• Major medical conditions

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (1)

• Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.

  PMID: 34231914 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Clonidine; Morphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alla Kushnir, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The family of the patient (baby), medical provider team and nursing will be masked to the specific arm. Investigator, unless is an active medical provider at the time, and pharmacist will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Principal Investigator

Model Details: Randomized double blind prospective trial

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 27, 2017
• Study Start: February 21, 2018
• Primary Completion: October 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)