跳至主要内容
临床试验/CTRI/2024/07/071457
CTRI/2024/07/071457已完成不适用

Neurodevelopment of Children with Retinopathy of Prematurity in Belagavi city: An Observational Study

Siddhi Kadam1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Bayley Scales of Infant & Toddler Development

研究概览

简要总结

Retinopathy of prematurity   results from disrupted angiogenesis as a result of preterm birth and exposure to higher levels of oxygen postnatally than in utero .Globally, retinopathy of prematurity  is common in both high income  and low income  countries, causing blindness or severe visual impairment in 20,000 to 30,000 children from 2000 to 2009. ROP is also linked to developmental delays, though this is less studied in low- and middle-income countries (LMICs).In India, retinopathy of prematurity  prevalence ranges from 44% to 47.27%, with significant prenatal and postnatal risk factors. While most studies focus on retinopathy of prematurity prevalence and risk factors, there is limited research on its link to neurodevelopmental disorders . A Tamil Nadu study found that 68.4% of infants with retinopathy of prematurity  had neurodevelopmental delays, highlighting the lack of awareness of this association in low- and middle-income countries.Hence the present study is intended to determine the neurodevelopment of children with ROP

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Month(s) 至 3.11 Month(s)(—)
性别
All

入选标准

  • Parents willing to participate in the study.
  • Children born between September 2021 and February 2022 , all gender, diagnosed with ROP.

排除标准

  • Children with congenital malformation, genetic conditions and having, or neurological problems associated with, and IVH .
  • Children with congenital malformations or genetic syndromes .

结局指标

主要结局

Bayley Scales of Infant & Toddler Development

时间窗: Baseline

(BSID 4)

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Siddhi Kadam
申办方类型
Other [self sponsored ]
责任方
Principal Investigator
主要研究者

Siddhi Kadam

KAHER Institute of Physiotherapy

研究点 (1)

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