Associate Provost for Research Boston University Medical Campus
NICHD - National Institute of Child Health & Human Development	Research Resources

Abstract

Abstract: DESCRIPTION (provided by applicant): Analysis of neonatal clinical trials involving twin births is complicated by the correlation that may arise from related individuals. Although the multiple-gestation rate may be cited as part of study entry characteristics, the handling of twin births for randomization or analysis is not commonly discussed. Methods currently exist for analyzing correlated data, but optimal methods for studies that may have as little as 10% of the individuals related have yet to be established. The proposed research aims to raise awareness of twin considerations in neonatal trial design and analysis and provide guidance on the selection of appropriate randomization schemes and statistical methods. The methods will be applied to clinical data from the NICHD Neonatal Research Network Randomized Clinical Trial of Intravenous Immune Globulin to Prevent Neonatal Infection in Very-Low-Birth-Weight (501-1500 g) Infants (IVIG trial). The research is significant, as failing to account for the hierarchical structure within complete twin births may impact the estimate of target sample size and the precision of treatment effect estimates and/or decisions regarding treatment efficacy. Thus, the effects of trial design and analysis need to be quantified and taken into consideration for studies that involve singletons and twin births.

Thesaurus Terms:
computer simulation, data collection methodology /evaluation, experimental design, health science research analysis /evaluation, statistics /biometry, twin /multiplet
clinical trial, computer data analysis, drug screening /evaluation, human therapy evaluation, immunoglobulin, mathematical model, microorganism disease chemotherapy, nosocomial infection
human data, low birth weight infant human, newborn human (0-6 weeks)

Institution:	BOSTON UNIVERSITY MEDICAL CAMPUS
	715 ALBANY ST, 560
	BOSTON, MA 021182394
Fiscal Year:	2006
Department:	BIOSTATISTICS
Project Start:	15-APR-2006
Project End:	30-JUN-2006
ICD:	NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
IRG:	CHHD