Author Contributions: Dr Bernstein, as principal
investigator of this study, had full access to all of the data in the study
and takes responsibility for the integrity of the data and the accuracy of
the data analysis.
Study concept and design: Wu, Armsby, Brugnara,
Acquisition of data: Ullrich, Wu, Armsby, Rieber,
Analysis and interpretation of data: Ullrich,
Armsby, Rieber, Brugnara, Shapiro, Bernstein.
Drafting of the manuscript: Ullrich, Rieber,
Brugnara, Shapiro, Bernstein.
Critical revision of the manuscript for important
intellectual content: Ullrich, Wu, Armsby, Rieber, Wingerter, Brugnara,
Statistical analysis: Ullrich, Rieber, Shapiro.
Obtained funding: Wu, Bernstein.
Administrative, technical, or material support:
Ullrich, Rieber, Brugnara, Bernstein.
Study supervision: Brugnara, Bernstein.
Financial Disclosures: Dr Brugnara currently
has a consulting agreement with Bayer Diagnostics and Dr Bernstein has had
a consulting agreement with Bayer Diagnostics in the past.
Funding/Support: Bayer Diagnostics funded this
study and provided laboratory reagents. The Department of Laboratory Medicine,
Children’s Hospital Boston, performed all laboratory analyses. Bayer
Diagnostics is the manufacturer of the ADVIA 120 hematology analyzer.
Role of the Sponsor: Bayer Diagnostics played
no role in the design and conduct of the study; collection, management, analysis,
or interpretation of the data; and preparation, review, or approval of the
manuscript. Statistical analyses were performed by Drs Ullrich and Shapiro
and Ms Rieber; none of them has any financial or personal connection with
Acknowledgment: We thank the Children’s
Hospital Primary Care Center and the research nurses, Anne Bailey, RN, Sandra
Smith, RN, Christine Bourgeois, RN, CPNP, MS, and Erin O’Mahony, RN,
for their valuable assistance with infant recruitment, enrollment, and follow-up;
Rebecca Stoltz, BA, for her assistance with data entry and manuscript review;
and Ellis Neufeld, MD, PhD, for his thoughtful insights.