NCT03762317

Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hennepin County Medical Center, Minneapolis · Academic / Other
• Sex: All
• Age: 36 Weeks – 45 Weeks
• Healthy volunteers: Not accepted

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

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	Clonidine	clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
DRUG	Placebo	Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Timeline

• Start date: 2018-04-30
• Primary completion: 2018-12-12
• Completion: 2018-12-12
• First posted: 2018-12-03
• Last updated: 2023-02-10
• Results posted: 2023-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study