Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

Hennepin Healthcare

Status and phase: Terminated; Phase 4

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Clonidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03762317

NAS

Details and patient eligibility

About

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)

Full 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

Enrollment: 10 patients

Sex: All

Ages: 36 to 45 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

clonidine

Active Comparator group

Description:

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

Treatment:

Drug: Clonidine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo