Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

• Status: Suspended
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hennepin County Medical Center, Minneapolis
• Treatments: Clonidine; Morphine

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