A prospective observational study to investigate the correlation analysis between neonatal hyperbilirubinemia and deafness gene: Study protocol clinical trial (SPIRIT compliant).

INTRODUCTION

There are many studies on the relationship between serum levels of hyperbilirubinemia and hearing impairment. However, the mechanism of hyperbilirubinemia on auditory impairment is not clear.

METHODS AND ANALYSIS: A total of 1000 children with hyperbilirubinemia who are mainly indirectly elevated bilirubin in the full-term neonatal ward of Xiamen Children's Hospital from March 2020 to September 2020 will be enrolled. Using second-generation high-throughput sequencing technology, 127 deaf-related genes were sequenced from the collected samples. At the same time, physical audiometry was performed on the selected persons and audiometry data were recorded.

DISCUSSION: In this study, we will combine gene sequencing with clinical indications of hyperbilirubinemia to find the loci suitable for high-frequency pathogenic deafness related to hyperbilirubinemia, so as to provide early guidance for deafness gene screening in children with hyperbilirubinemia.

TRIAL REGISTRATION: Chinese Clinical trial registry: ChiCTR2000030075.