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Co-Bedding Twins: How Pilot Study Findings Guided Improvements in Planning a Larger Multicenter Trial

Hayward, Kathryn; Campbell-Yeo, Marsha; Price, Sheri; Morrison, Della; Whyte, Robin; Cake, Heather; Vine, Jocelyn

doi: 10.1097/01.NNR.0000263967.24125.db
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Background: Co-bedding, a developmental care practice for twins and multiples, has been theorized as a strategy to decrease the adverse neurodevelopmental effects that may be associated with hospitalization.

Objective: The aim of this study was to determine the feasibility of study design, methods, and the measurement of desired outcomes for the development of a larger multicentered study.

Results: Study findings were used to estimate effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up. Results were incorporated in the development of a larger multicentered trial grant proposal.

Discussion: Pilot studies can play an important role in the development of a competitive grant proposal and efficient conduct of a research trial. Pilot studies strengthen a proposal by providing essential baseline information. A general overview of the purpose of pilot studies is provided here, along with a description of the process of using findings from a pilot study to inform the development of a larger multisite trial. Findings from this pilot study examining the effects of co-bedding on twins and their parents are used to revise the research protocol for a larger multisite trial. These changes, which lead to improvement to the protocol, and the rational for these changes are highlighted.

Kathryn Hayward, RN, BScN, IBCLC, is Assistant Professor and Masters Student, Dalhousie University School of Nursing; and Staff Nurse, IWK Health Centre, Halifax, Nova Scotia, Canada.

Marsha Campbell-Yeo, MN, is Neonatal Nurse Practitioner, IWK Health Centre, Halifax, Nova Scotia; Adjunct Professor, Dalhousie University School of Nursing, Halifax, Nova Scotia; and Doctoral Student, McGill University, Montreal, Quebec, Canada.

Sheri Price, MN, is Research Associate, Interdisciplinary Research, IWK Health Centre, Halifax, Nova Scotia; Adjunct Faculty, Dalhousie University School of Nursing, Halifax, Nova Scotia; and Doctoral Student, University of Toronto, Toronto, Ontario, Canada.

Della Morrison, MN, is Neonatal Nurse Practitioner; Heather Cake, MA, is Psychologist; and Jocelyn Vine, MN, is Vice President, Patient Care, IWK Health Centre, Halifax, Nova Scotia, Canada.

Robin Whyte, MB, is Associate Professor and Neonatalogist, IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada.

Editor's Note Materials documenting the review process for this article are posted at http://www.nursing-research-editor.com.

Accepted for publication November 6, 2006.

Thank you to Kelly Robson for her assistance with data collection; Colleen O'Connell for her support with data analysis and completion of the power analysis for sample size for the multisite trial; and Celeste Johnston for her ongoing mentorship throughout the development of this pilot study and the larger multisite trial.

Corresponding author: Kathryn Hayward, RN, BScN, IBCLC, Dalhousie University School of Nursing, 5869 University Avenue, Halifax, Nova Scotia, Canada B3H 3J5; or PO Box 9700 IWK Health Centre, 5850/5980 University Avenue, Halifax, Nova Scotia, Canada B3K 6R8 (e-mail: kathryn.hayward@dal.ca).

© 2007 Lippincott Williams & Wilkins, Inc.