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 inclusion of the study and its findings. Protection of Human Participants This study goal is to differentiate the efficacy of colliding 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 he 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 (Curran, et al 2013). The parents or legal guardians entered the babies into the study voluntarily. The Institutional Review Board of testate Children’s Hospital approved this study ROR to the enrollment of the newborns. Data Collection The major independent variables are noted to be the two adjunct therapies for NAS being studied. Colliding along with the morphine sulfate dose deemed appropriate by the provider is one of the two adjunct therapies.
Phenobarbital and morphine sulfate as dosed by the provider is considered the second independent variable. The data collection for this study was collected from June 201 0 until June 2012. The Modified Finnegan score was chosen by the study as the basis for the dosing protocol that was developed. The Modified Finnegan score provided for the escalation and De-escalation of the morphine sulfate dosages (Curran, et al 2013). The Modified Finnegan score was also utilized to dictate the dosages of both the colliding and Phenobarbital.
Each baby in each of the two study groups was given a specific dose of morphine sulfate and adjunct therapy drug. The babies were scored every three hours using the Modified Finnegan score. The morphine sulfate dose was reduced by ten percent every twenty-four hours if the Modified Finnegan score was less than eight. The babies on the colliding adjunct harpy were monitored for changes in their blood pressure and brickyard, as these are two major side effects from colliding. The babies given Phenobarbital were monitored for over sedation.
The data was collected to study the time needed to wean the babies off of the morphine sulfate. This was considered to be the primary outcome of this study (Curran et al, 2013). Analysis. The statistical analysis data was entered into Stats version 12. 1 as a means clinical analysis. The invariable comparisons of data across the study groups were reported using the Wilcox rank-sum test (Curran et al, 2013). The sample size was estimated using the computer program called PASS (Curran et al, 2013). This was a randomized non-blinded trial at a single NICE.
The potential for bias might be great if the hospital had not retrained their staff on proper scoring using the Modified Finnegan scoring tool. This along with continuity of care by nursing, following the weaning protocol and strict adherence to the study protocol all but eliminated biases. Findings. The study started with 82 participants 68 of whom were randomized and placed into the clinical trial. The 68 were divided into groups and each was score using he Modified Finnegan score to determine the weaning process.
The researchers viewed both adjunct therapies as equally efficacious in controlling NAS Symptoms. The researchers found that the babies treated with morphine sulfate and Phenobarbital had clinically non-significant shorter inpatient stays. These babies actually went home on the Phenobarbital and some remained on the therapy for up to eight months after discharge. The babies on the colliding went home in approximately the same amount of time as the babies on the Phenobarbital however, upon discharge the babies were completely off of all medications. Therefore, reducing health-care costs greatly.
The researchers listed the following limitations to their study: the inability to blind the two groups for the study medications, the different dosing units (micrograms versus milliards) and different dosing intervals. The presentation of the data was logically expressed in a coherent manner. The implications of these findings will allow IONIC nurses and providers to allow for different adjunct therapy based on the needs and criteria of each baby who shows signs of NAS. This study clearly defines colliding as a viable option for the treatment of NAS.