Abdel-Rahman, Susan M. http://orcid.org/0000-0002-5815-2029
,
Paul, Ian M.
Delmore, Paula
Chen, Jia-Yuh
Mills, Mary
Greenberg, Rachel G.
Funding for this research was provided by:
National Institute of Child Health and Human Development (HHSN2752010000031)
Article History
Received: 22 April 2019
Accepted: 16 January 2020
First Online: 22 January 2020
Ethics approval and consent to participate
: All infants were enrolled following receipt of verbal parental informed consent under a protocol that was reviewed and approved by the Institutional Review Boards at Children’s Mercy (IRB# 16110806), Penn State Children’s Hospital (IRB# 00006333), and Wesley Medical Center (IRB# 00002143). A waiver of documentation of permission was authorized by the IRBs because 1) the study presented minimal risk to the participant, 2) investigators collected no protected health information, and 3) a signed permission form would be the only record linking the participant and the study introducing an unnecessary risk from breach of confidentiality.
: Not applicable.
: Children’s Mercy (CM) has been issued a patent for a related weight estimation device for children that <b>does not</b> extend to the device described in this manuscript. CM will file a 510(k) seeking marketing clearance from the U.S. Food and Drug Administration for the Mercy babyTAPE; however, CM does not have, never has had, and will not develop an interest in extracting royalties for use of these devices in developing countries or in situations in which royalties could hinder adoption of this device.