2.1 Study design and participants
The study was performed in
accordance with the Declaration of Helsinki principles and Good Clinical
Practice. The study protocol was approved by the Institutional Review
Board of Wuhan Children’s Hospital and Tongji Hospital, Tongji Medical
College, Huazhong University of Science and Technology (Wuhan, China).
Written informed consent was waived because of the emergence of this
infectious disease.
Medical record review was conducted using the institution’s database
from January 21st to March 14th 2020
in Wuhan Children’s hospital and Tongji Hospital. In a prior study
included only 20 patients in Wuhan children’s hospital, it only
described the general clinical and CT features without follow-up, and
didn’t include the evaluation of RT-PCR13.
Inclusion criteria were: (a) age <16 Years old, inpatients; (b)
positive RT-PCR results of COVID-19; (c) CT in the picture archiving and
communication system (PACS) performed. (d) discharged patients only.
Exclusion criteria were: (a) CT scans were performed greater than 1
months; (b) patients with suboptimal image quality for analysis due to
breathing motion artifact; (c) unknown date of RT-PCR.
Pharyngeal swab samples of all the pediatric patients in our study were
collected, and the SARS-CoV-2 RNA was detected by RT-PCR. RT-PCR kits
from Wuhan HUADA biotechnology Co., Ltd, Shanghai Huirui Biotechnology
Co., Ltd or Shanghai BioGerm Medical Biotechnology Co., Ltd. These were
approved by China Food and Drug Administration for the detection of
SARS-CoV-2 nucleic acid.
The discharge criteria were as follows: (1) normal temperature for at
least 3 days; (2) significantly improved respiratory symptoms; (3) two
consecutive SARS-CoV-2 throat swabs with negative RT-PCR results were
performed at least 24 hours apart.