The Role of the Clinical Research Coordinator in Multicenter Clinical Trials

The clinical research coordinator plays a crucial role in organizing a site's participation in the expanding arena of multicenter medical and pharmacologic clinical trials. This summary clarifies the role of the clinical research coordinator for inexperienced staff members assuming these responsibilities and outlines planning procedures leading to successful implementation. Emphasis is placed on establishing an interdependent relationship with the principal investigator, careful protocol assessment, team building, and staff feedback. Useful tools such as study manuals and physicians' study orders are described.     

Indwelling Versus Intermittent Feeding Tubes in Premature Neonates

Objective: To determine the effect of indwelling versus intermittent feeding tube placement on weight gain, apnea, and bradycardia in premature neonates.
Design: Eligible subjects were assigned randomly to either feeding tube method. Each subject was followed for 6 days.
Setting: The study was conducted in a secondary level neonatal intensive-care unit (NICU), a tertiary level NICU in a perinatal center, and a tertiary level NICU in a referral center.
Patients/Participants: Neonates who were 24–34 weeks gestational age, developmentally appropriate for gestational age, medically stable, on full enteral feedings through an orogastric or a nasogastric tube, and not fluid restricted. Ninety-three neonates were enrolled-49 in the indwelling group and 44 in the intermittent group. Nine neonates did not complete the study.
Interventions: Nasogastric indwelling feeding tubes were placed and left in site for up to 3 days. Orogastric intermittent feeding tubes were placed for each feeding and removed at completion of the feeding.
Main outcome measures: Weight gain, apnea, and bradycardia. Results: Members of both groups had similar demographic characteristics, clinical problems, and nutritional intake. No statistical differences were found between the two groups in weight gain or episodes of apnea and bradycardia.
Conclusions: There were no statistically or clinically significant differences between the two groups. The intermittent method of feeding is more expensive. Because no clinical differences were found, the type of tube placement chosen for feeding the premature infant may be based on economics.     

Neonatal Sucking Behaviors

Neonatal sucking responses or behaviors have been of great interest to researchers and clinicians since the early 1800s. Since 1960, there has been a resurgence of interest in the objective study of sucking behaviors in both the psychological and medical literature. The studies have examined both nutritive and non-nutritive sucking measurements. Sucking behaviors have been studied to understand the development of the feeding mechanism as well as to track neurobehavioral development. The relationship between sucking behaviors and behavioral organization of the newborn are considered, along with a historical perspective of sucking measurements, relevant literature on nutritive sucking, physiologic correlates, differences in breast and bottle feeding patterns, non-nutritive sucking, and factors that modify sucking organization. Implications for nursing practice will be discussed.     

Mentoring in inservice training for child care workers

A model for training the trainers of child care providers that employs Vygotsky's framework of the Zone of Proximal Development is described. This efficient training mechanism proposes mentoring relationships as a means to meet the developmental needs of experienced child care professionals and improve the quality of existing child care programs.The authors would like to thank Dr. Bille Thomas and the satellite resource center directors and staff members for their work on the project.     

Preconditions for and consequences of self-determination: the psychiatric patient's point of view

In the context of an interview study concerned with self-determination in psychiatric patients, this paper describes the preconditions for and consequences of self-determination from the point of view of psychiatric patients themselves. The data were collected in semi-structured interviews with long-term psychiatric patients ( n =72) and analysed using the method of content analysis. Responses on the preconditions for self-determination were grouped into three categories: firstly, there were those who said that reference to self-determination in the case of psychiatric patients is nonsense; secondly, there were those who said that self-determination requires no preconditions; and thirdly, there were those who said that there are certain preconditions, such as the ability to think and make decisions, activity, obedience, and illness. Both positive and negative consequences were identified in situations where self-determination is maintained, but only negative consequences in situations where self-determination is lost. On the basis of these tentative results, self-determination seemed to be relevant in psychiatric nursing. We are continuing to develop and test an instrument for the evaluation of the opportunity for self-determination in clinical practice.     

Sensory functions of institutionalized Romanian infants: A pilot study

Infants living in an orphanage (n = 22) in Romania were assessed on the Test of Sensory Functions in Infants (TSFI). Testing of the institutionalized infants was done before and 6 months after an enriched caregiver intervention program. Results showed significant changes in areas of reactivity to tactile deep pressure, visual-tactile integration, oculomotor control, reactivity to vestibular stimulation and total test responses. No significant changes occurred in the area of adaptive motor functions. Effects of sensory deprivation resulting from institutional settings and changes that can occur from enriched caregiver environments are discussed.     

Analysis of the epsilon-sarcoglycan gene in familial and sporadic myoclonus-dystonia: evidence for genetic heterogeneity.

The epsilon-sarcoglycan gene (SGCE) on human chromosome 7q21 has been reported to be a major locus for inherited myoclonus-dystonia. Linkage to the SGCE locus has been detected in the majority of families tested, and mutations in the coding region have been found recently in families with autosomal dominant myoclonus-dystonia. To evaluate the relevance of SGCE in myoclonus-dystonia, we sequenced the entire coding region of the epsilon-sarcoglycan gene in 16 patients with either sporadic or familial myoclonus-dystonia. No mutations were found. This study suggests that epsilon-sarcoglycan does not play an important role in sporadic myoclonus-dystonia and supports genetic heterogeneity in familial cases.     

Infantile depression,nonorganic failure to thrive,and DSM-III-R: A different perspective

A controversy exists regarding the classification of nonorganic failure to thrive within the psychiatric nomenclature. There are a number of DSM-III-R diagnoses that may be applied to NOFTT, including Reactive Attachment Disorder of Infancy (RADI) and Major Depressive Disorder (MDD). The behaviors characteristic of NOFTT are symptomatic of depression, and are similar to those exhibited by infants with anaclitic depression as well as those of the adult with depression. The correspondence of the behaviours of NOFTT and the DSM-III-R criteria for Major Depression are reviewed, as are the conceptual and therapeutic reasons to view NOFTT infants as suffering from Depression.