The purpose of this research critique is to inform the reader of a randomized clinical study regarding the treatment of Neonatal Abstinence Syndrome (NAS). This writer is interested in the treatment of drug exposed infants and the goals of reducing babies’ hospitalization in the Neonatal Intensive Care Unit (NICU). The study researches the adjunct therapy for treatment of NAS. The study will be broken down into the following units: protection of human participants, type of data collection utilized in the study, data management and analysis, findings and interpretation of these findings and finally the conclusion of the study and its findings.
Protection of Human Participants
This study’s goal is to differentiate the efficacy of clonidine versus phenobarbital in adjunct therapy with morphine sulfate in the treatment of NAS. One of the benefits of this study is the importance of standardization of a weaning protocol. The weaning protocol did not change from day to day and provider to provider as can be the case outside of the study. Another benefit is the predefined measures for each study group that were considered adverse events. These measures worked as a safety net to ensure the study was done safely and not causing harm to the babies. One noted concern/risk noted by the author was the potential for prolonged exposure to phenobarbital on a baby’s developing brain. The concern is the phenobarbital may cause behavioral compromises in the babies in the future. Informed consent was obtained from parents or the legal guardians of the babies after the babies had been identified as at risk for NAS (Surran, et al 2013). The parents or legal guardians entered the babies into the study voluntarily. The Institutional Review Board of Baystate Children’s Hospital approved this study prior to the enrollment of the newborns.
Data Collection
The major independent variables are noted to be the two adjunct therapies for NAS being studied. Clonidine