2.3 Subjects
The study has been registered in ClinicalTrials.gov (Number:
NCT03984266). Inclusion criteria (meet the Both): All newborns
(including hospitalized infants and infants with abnormal results of
conventional NBS); the guardian signs the informed consent and agrees to
participate. Exclusion criteria (Meet one or more of the
following criteria): Other similar clinical studies are underway;
received transfusion of allogeneic blood products in recent 2 weeks.Rejection criteria : Specimen cannot be tested due to improperly
collected or stored; samples with unstandardized data; Samples without
follow-up data; Guardian’s request to withdraw.
From Oct 2019 to Sep 2021, a total
of 3423 neonatal subjects were enrolled from 5 hospitals:
Children’s Hospital of Chongqing
Medical University, Inner Mongolia Maternal and Child Health Hospital,
Northwest Women and Children’s Medical Center, Dalian Maternal and Child
Health Hospital, and Xuzhou Maternal and Child Health Care Hospital.