Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

NCT03762317 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: NAS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• Duration of Pharmacotherapy for NAS

  The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Secondary Outcomes (5)

• Duration of Hospital Stay

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

• Maximum Dose of Morphine Used

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

• Average Daily Dose of Oral Morphine Over Hospital Stay

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

• Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

• Total Number of Episodes of Blood Pressure (mm of Hg) Variability

  From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Study Arms (2)

clonidine

ACTIVE COMPARATOR

Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period

Drug: Clonidine

Placebo

PLACEBO COMPARATOR

Placebo solution will be given for the duration of the study period

Drug: Placebo

Interventions

Clonidine DRUG

clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine

clonidine

Placebo DRUG

Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Placebo

Eligibility Criteria

• Age: 36 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
• Gestational age greater than or equal to 36 weeks
• Less than or equal to 48 hours of treatment with morphine for NAS

You may not qualify if:

• Presence of seizures
• Congenital malformations, genetic syndromes or the presence of TORCH infections
• Major medical problems
• Heart rate and/or blood pressure instability

Sponsors & Collaborators

• Hennepin County Medical Center, Minneapolis: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Clonidine

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

Results Point of Contact

• Title: Dr. Kunal Gupta
• Organization: Hennepin County Medical Center

kunal.gupta@hcmed.org

6128732677

Study Officials

• kunal gupta

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

• vinay sharma

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 3, 2018
• Study Start: April 30, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)