Representativeness of enrollment into a perinatal research repository

Abstract

Objective: To describe enrollment and compare demographic and clinical characteristics of neonates enrolled in the perinatal research repository (PRR) with eligible, but non-enrolled neonates.

Methods: Characteristics from enrolled infants were compared with eligible, but non-enrolled infants using t-tests, Wilcoxon rank tests and χ² tests.

Results: Between 1 January 2010 and 31 December 2011, 622 infants admitted to the neonatal intensive care unit (NICU), born <37 weeks were screened for the PRR were eligible for enrollment. Of these, 233 enrolled in the study. There were no significant differences between enrolled and non-enrolled infants with regard to race, birth weight, gestational age and Apgar scores. Enrolled patients had a significantly longer length of stay [mean (standard deviation) = 55.0 (58.9) versus 38.0 (45.8) days; p < 0.01]. Mortality was significantly greater in the non-enrolled group (11.7 versus 3.0%; p < 0.01). Both groups had a similar total number of diagnoses [mean (standard deviation) = 5.7 (3.1) versus 5.8 (3.2)]; however, among survivors enrolled infants had slightly lower prevalence of hypoxic ischemic encephalopathy (0.0 versus 2.9%; p < 0.01) and seizures (1.8 versus 6.4%; p < 0.01). There were no significant differences in enrollment by prevalence of other morbidities.

Conclusions: These results suggest that a specimen collecting repository can enroll a sufficiently representative sample of eligible patients.

• Neonatal intensive care unit
• perinatal repository
• representative sample
• research repository
• study recruitment

Acknowledgements

The authors thank the NCH's NICU staff and the NICU infants and families who participated in this study, as well as the clinical research staff of the Ohio Perinatal Research Network and Children's Hospital Neonatal Database for their contributions to this project and dedication to improving neonatal outcomes.

Declarations of interest

The authors report no conflicts of interest.

This work was supported by Nationwide Children's Hospital. The authors have no financial relationships relevant to this article to disclose. No payment in the form of an honorarium, grant, or any other form of payment was given to produce this article.

The initial draft of this article was co-written by Pamela A. Moorehead, BS and Dr Reena Oza-Frank, PhD, RD.