Clinical Trial: Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Brief Summary: The purpose of this study is to determine whether a medication, Clonidine can reduce the number of days a baby spends in the hospital and the number of days of medical treatment of withdrawal from Neonatal Abstinence Syndrome (NAS) as compared to Morphine Sulfate (used in routine care) .
Detailed Summary:
Finnegan scoring system will be initiated for the subjects that are at risk and are exhibiting withdrawal symptoms. The nursing staff will be using the Modified Finnegan Scoring system currently used in Cooper Hospital that all had been trained in. Nurses will be blinded to the specific medication being used for treatment of neonatal abstinence syndrome (NAS) during the study.
The scoring will be initiated for the babies that are at risk for NAS and are having symptoms of withdrawal. This is determined by the maternal history of use/abuse of substances or prescription medications that can result in NAS (Neonatal Abstinence Syndrome) in the neonate and/or if there is a positive urine toxicology screen.
Patients will be recruited if there is at risk for NAS and enrolled in the study if the patient exhibits withdrawal symptoms requiring pharmacologic treatment. The indication for initiating therapy is three consecutive Finnegan scores of 8 or greater. The subjects will be randomized to the control (standard of care) group or the intervention (study) group once the need for initiating pharmacologic therapy is established. A strict protocol will be followed.
For each baby undergoing NAS scoring and if therapy needs to be initiated then physical therapy will be consulted.
Blood pressure and heart rate will be checked once treatment is started:
- Check every three or four hours (with hands on care) for the first 24 hours (day 1 of medication) of treatment.
- Check every eight hours (or 6 hours with care) for the next 24 hours (day 2 of medication).
- Check every twelve hours for day 3 of
Sponsor: The Cooper Health System
Current Primary Outcome: Length of stay [ Time Frame: From birth through discharge from the hospital, up to 100 days. ]
Duration of hospitalization
Original Primary Outcome: Same as current
Current Secondary Outcome: Length of treatment [ Time Frame: From initiation of medical treatment through last dose of medication given, up to 100 days ]
Duration of treatment of Neonatal Abstinence Syndrome with medication/pharmacological treatment from first day initiated until medication has been stopped or patient discharged home
Original Secondary Outcome: Same as current
Information By: The Cooper Health System
Dates:
Date Received: March 13, 2017
Date Started: March 2017
Date Completion: December 2018
Last Updated: March 21, 2017
Last Verified: March 2017
