跳至主要内容
临床试验/CTRI/2025/09/095226
CTRI/2025/09/095226尚未招募不适用

Neurodevelopmental Outcomes in Neonates with Rotaviral Encephalopathy: A Prospective Cohort Study

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Neurodevelopmental outcomes - motor , language and personal social

研究概览

简要总结

This is a prospective cohort study involving infants previously admitted to the NICU for seizures or encephalopathy and subsequently diagnosed with rotavirus encephalopathy. Follow-up neurodevelopmental outcomes will be assessed in the NICU highrisk clinic. Parental consent will be obtained from eligible participants. All infants meeting the inclusion criteria will be identified from the NICU and MRD admission-discharge records. Medical records will be accessed from the hospital’s medical records department for NICU data. Parents will be contacted by phone and via mail and are requested to visit the NICU HRFU clinic for neurodevelopmental follow up visits every 3 to 6 months until 3 years of age. Diagnoses will be verified through documented laboratory confirmation of rotavirus infection in the records, along with MRI evidence of rotaviral encephalopathy. Baseline information on demographics, birth history gestational age, birth weight, and clinical presentation age at presentation, symptoms such as seizures or altered mental status) will be recorded. The clinical profile, including symptom onset and duration (documenting when symptoms began and how long they lasted); laboratory and imaging results (including rotavirus test results, complete blood count, biochemical profiles, cerebrospinal fluid CSF analysis if conducted, and electroencephalography EEG and neuroimaging findings of the MRI brain treatment administered type and duration of treatments given, e.g., antivirals, antiepileptics, supportive care); and outcome at NICU discharge neurological status at discharge, resolution of seizures or encephalopathy, and any noted complications will be extracted from the hospital’s electronic and/or physical records. Additional data on any comorbid conditions or congenital abnormalities will also be included. Neurodevelopmental outcomes between 1 and 3 years of age will be evaluated using the Denver Developmental Screening Test DDST. The Developmental Assessment Scale for Indian Infants DASII will be used to further assess motor and mental scores in participants who do not pass the DDST screening test. Data from other neurological assessments during follow-up will also be recorded follow-up imaging, EEG. Participants who are found to have neurodevelopmental issues will be provided with standard treatments with occupational therapy, physiotherapy, speech and language therapy, and vision, and hearing support as standard of care.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 2.00 Year(s)(—)
性别
All

入选标准

  • Infants who were admitted to the NICU with seizures or encephalopathy. AND.
  • Diagnosed with positive rotaviral infection (stool PCR) with clinical and MRI brain evidence of encephalopathy. AND.
  • Parents give consent for follow-up in NICU OPD /High-risk OPD.

排除标准

  • Neonates with other confirmed central nervous system (CNS) infections or encephalopathy (e.g., meningitis, bacterial encephalitis, Hypoxic ischemic encephalopathy).
  • Cases with incomplete medical records or missing follow-up.
  • Neonates with genetic or metabolic disorders that could affect neurological outcomes.

结局指标

主要结局

Neurodevelopmental outcomes - motor , language and personal social

时间窗: 1-3 years age

次要结局

  • Vision, Hearing(1-3 years age)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shruthi Bharadwaj

KMC Manipal

研究点 (1)

Loading locations...

相似试验

Long-Term Neuro Development in Newborns Affected by... | 临床试验