Conditions: Neonatal Abstinence Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

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

Arms:
arm 1: Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period arm 2: Placebo solution will be given for the duration of the study period

Interventions: intervention 1: Clonidine intervention 2: Placebo
Intervention descriptions: intervention 1: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine intervention 2: Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Protocol document:
Prot_SAP_001.pdf: 
 
Official Title: Clonidine as Adjunct to Morphine in the Management of Term and 
Near-term Infants with Neonatal Abstinence Syndrome 
NCT#: 03762317 
Document Date: November 30, 2018