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Volume 156, Issue 2 , Pages 202-208 , February 2010

Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study

Anna Maria Hibbs, MD, MSCE
- Department of Pediatrics, Case Western Reserve University and Rainbow Babies and Children's Hospital, Cleveland, OH
- Reprint requests: Dr Anna Maria Hibbs, Division of Neonatology, Rainbow Babies and Children's Hospital, 11100 Euclid Avenue, Suite 3100, Cleveland, OH 44106.
Dennis Black, PhD
- Department of Biostatistics, University of California San Francisco, San Francisco, CA
Lisa Palermo, MA
- Department of Biostatistics, University of California San Francisco, San Francisco, CA
Avital Cnaan, PhD
- Center for Clinical and Community Research, Children's National Medical Center, Washington, DC
Xianqun Luan, MS
- Quality Data Services Inc, King of Prussia, PA
William E. Truog, MD
- Department of Pediatrics, Children's Mercy Hospitals and Clinics, Kansas City, MO
Michele C. Walsh, MD, MS
- Department of Pediatrics, Case Western Reserve University and Rainbow Babies and Children's Hospital, Cleveland, OH
Roberta A. Ballard, MD
- Department of Pediatrics, University of California San Francisco, San Francisco, CA

Received 20 November 2008 ,Revised 29 July 2009 ,Accepted 26 August 2009.

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Supported by National Institutes of Health grant K23-HD056299. The NO CLD trial has been used as a case study. Disclosures with regard to that study are as follows: Supported by grants from the National Institutes of Health (U01-HL62514, P50-HL56401, P30-HD26979, P30-MRDDRC, and P30-HD26979) and the General Clinical Research Centers Program (M01-RR00240, M01-RR00084, M01-RR00425, M01-RR001271, M01-RR00064, and M01-RR00080). IKARIA (formerly INO Therapeutics) provided study gas and masked delivery systems for the primary NO CLD trial. M.C.W. and R.A.B. received support from IKARIA to fund completion of 24-month follow-up and data analysis. A.M.H. received reimbursement for travel to investigator meetings as part of these grants. A trainee in the Division of Neonatology, Rainbow Babies and Children's Hospital, received grant support from IKARIA. IKARIA did not play any role in the design, analysis, interpretation, or reporting of the study.