Clinical trial NCT03762317: Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
Official title: Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: Hennepin County Medical Center, Minneapolis
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 36
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of Pharmacotherapy for NAS
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Secondary outcomes:
measure: Duration of Hospital Stay
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
measure: Maximum Dose of Morphine Used
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
measure: Average Daily Dose of Oral Morphine Over Hospital Stay
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
measure: Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
measure: Total Number of Episodes of Blood Pressure (mm of Hg) Variability
timeFrame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: kunal gupta
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin County Medical Center, Minneapolis
name: vinay sharma
role: PRINCIPAL_INVESTIGATOR
References: