跳至主要内容
临床试验/CTRI/2024/10/074557
CTRI/2024/10/074557尚未招募不适用

Ambispective study to assess Universal Newborn Hearing Screening Program

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 913 人开始时间: 2024年10月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
913
试验地点
1
主要终点
To assess differences in outcome

研究概览

简要总结

Though there are OAE and AABR screening done in many hospitals in India, there is a paucity of research in analysing the outcomes of the screening program. There has been no dedicated research on influencing factors of ‘who is doing the screening and where is it being done’ with respect to the newborn hearing screening test. As recommended by Joint Committee on Infant Hearing it is important to document and analyse the coverage, drop out percentage, follow up percentage of any newborn hearing screening program as they will serve as the quality indicators for the program. Also analysing the existing program will help in further corrections as well as serve as a guide for the wide spread implementation of the program throughout the country.

研究设计

研究类型
Interventional
分配方式
Na

入排标准

年龄范围
1.00 Day(s) 至 1.00 Year(s)(—)
性别
All

入选标准

  • All newborn children in the neonatology ward, NICU.

排除标准

  • Children whose parents are not willing to participate in the study.

结局指标

主要结局

To assess differences in outcome

时间窗: Within 1 month of child birth

of OAE with different testing

时间窗: Within 1 month of child birth

environment (ward/NICU/

时间窗: Within 1 month of child birth

isolated room).To assess differences in outcome

时间窗: Within 1 month of child birth

of OAE when done by trained

时间窗: Within 1 month of child birth

(audiologist) and untrained

时间窗: Within 1 month of child birth

professionals (nursing staff).To enumerate the difficulties

时间窗: Within 1 month of child birth

faced during screening and

时间窗: Within 1 month of child birth

describe best practice protocols

时间窗: Within 1 month of child birth

on who and where on UNHS.To assess the incidence of

时间窗: Within 1 month of child birth

Auditory Neuropathy Spectrum

时间窗: Within 1 month of child birth

Disorder (ANSD) in newborns.To assess the reasons for loss to

时间窗: Within 1 month of child birth

follow up

时间窗: Within 1 month of child birth

次要结局

  • To assess the coverage, pass(and refer percentage, drop)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Narendhiran S

AIIMS New Delhi

研究点 (1)

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