| CTRI Number |
CTRI/2026/02/103774 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Behavioural problems among children with dengue fever and non-dengue fever |
|
Scientific Title of Study
|
Behavioural Sequelae of Dengue Related Hospitalizations in Children A Comparative Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghavendra |
| Designation |
PhD Scholar in Psychosocial Support in Disaster Management |
| Affiliation |
National Instittue of Mental Health and Neuro sciences,Bengalore |
| Address |
Department of Psychosocial support in Disaster Management,
4th floor of NIMHANS Digital Academy, NIMHANS
Bangalore, Karnataka-560029
Bangalore KARNATAKA 560029 India |
| Phone |
9535326906 |
| Fax |
|
| Email |
kukkehalliraghavendra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Dinakaran D |
| Designation |
Assistant Professor of Psychiatry |
| Affiliation |
National Instittue of Mental Health and Neuro sciences,Bengalore |
| Address |
Department of Psychosocial support in Disaster Management,
4th floor of NIMHANS Digital Academy, NIMHANS
Bangalore, Karnataka-560029
Bangalore KARNATAKA 560029 India |
| Phone |
81973 11288 |
| Fax |
|
| Email |
dinanimhans@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Raghavendra |
| Designation |
PhD Scholar in Psychosocial Support in Disaster Management |
| Affiliation |
National Instittue of Mental Health and Neuro sciences,Bengalore |
| Address |
Department of Psychosocial support in Disaster Management,
4th floor of NIMHANS Digital Academy, NIMHANS
Bangalore, Karnataka-560029
Bangalore KARNATAKA 560029 India |
| Phone |
9535326906 |
| Fax |
|
| Email |
kukkehalliraghavendra@gmail.com |
|
|
Source of Monetary or Material Support
|
| India Gandi Institute of Child health,Bengalore |
| National Institute of Mental Health and Neuro sciences,NIMHANS,Bengalore - 560029 |
|
|
Primary Sponsor
|
| Name |
Mr.Raghavendra |
| Address |
4th floor of NIMHANS Digital Acadamy,
Department of Psychosocial Support in Disaster Management,NIMHANS,Bengalore-560029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ashwini M A |
Dr. Ashwini M A
Assistant Professor
Dept. of Neurovirology
NIMHANS, Bengaluru - 560029
|
| Dr Dinakaran D |
Dr. Dinakaran D
Assistant Professor of Psychiatry
Dept. of PSSDM, NIMHANS
Bengaluru - 560029
|
| Dr G V Basavaraja |
Dr. G. V. Basavaraja
Professor & In-Charge of PICU
Indira Gandhi Institute of Child Health
Bengaluru - 560029
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B V Basavaraja |
Indira gandhi institute of child health |
3rd floor of Pediatric ICU UNIT
Department of Pediatric Medicine
Indira gandhi institute of child health Bengalore 560011 Bangalore KARNATAKA |
8277021754
basavgv@gmail.com |
| Raghavendra |
National Institute of Mental Health and Neuro sciences,Bengalore |
4th floor of NIMHANS Digital Academy,
Department of Psychosocial Support in Disaster Management,
National Institute of Mental Health and Neuro sciences,Bengalore-560029 Bangalore KARNATAKA |
09535326906
kukkehalliraghavendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with dengue fever and Children with Non Dengue fever |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to upto18 years
2. Hospitalized with laboratory-confirmed dengue (Dengue NSI and/or anti-dengue IgM positive) or children with fever other than Dengue fever.
3. Medically stable at the time of discharge
4. Consent from parent/guardian and assent from the child
5. Fluent in Kannada or Hindi or English
6. Families from in and around the districts of BBMP
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing diagnosed neurodevelopmental or psychiatric conditions
2. Chronic medical illness or ongoing use of medications affecting sleep or cognition
3. Children with encephalitis syndrome during the admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess, compare, and longitudinally follow up the emotional, behavioural issues, sleep disturbances, fatigue, and cognitive impairments in children hospitalised with dengue fever with those hospitalised with other fever |
Baseline assessment will be conducted during hospitalization.
Follow-up assessments will be conducted at the 1st and 3rd months after discharge from the hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess & compare the prevalence of emotional, behavioural, & sleep related problems in children hospitalized with dengue fever with those hospitalised with other fever at one-month post discharge.
• To assess & compare fatigue, sleep & cognitive impairments in children hospitalised with dengue fever with those hospitalised with other fever.
• To examine the association between the severity of dengue infection (along with specific Dengue serotype), parental stress levels & the extent of psychosocial, sleep, fatigue, cognitive impairments in children.
• To identify key risk factors (such as duration of illness, hospitalization period, & socio-demographic factors) associated with worse outcomes in children.
|
Baseline assessment will be conducted during hospitalization.
Follow-up assessments will be conducted at the 1st & 3rd months after discharge from the hospital |
|
|
Target Sample Size
|
Total Sample Size="260" Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Topic: “Behavioural Sequelae of Dengue Related Hospitalizations in Children: A Comparative Observational Study”
Primary Investigator: Mr. Raghavendra
Aim of the study: To assess, compare, and longitudinally follow up the emotional, behavioural issues, sleep disturbances, fatigue, and cognitive impairments in children hospitalised with dengue fever with those hospitalised with other fever.
Objectives of the study:
- To assess and compare the prevalence of emotional, behavioural, and sleep related problems in children hospitalized with dengue fever with those hospitalised with other fever at one-month post discharge.
- To assess and compare fatigue, sleep and cognitive impairments in children hospitalised with dengue fever with those hospitalised with other fever.
- To examine the association between the severity of dengue infection (along with specific Dengue serotype), parental stress levels and the extent of psychosocial, sleep, fatigue, cognitive impairments in children.
- To identify key risk factors (such as duration of illness, hospitalization period, and socio-demographic factors) associated with worse outcomes in children.
Process of the study: Phase: I: Identification and Assessment during hospitalization After obtaining institutional ethical clearance, participants will be approached during their hospital stay. Informed consent and assent will be obtained from the child and their parents. Information about the child will be collected from the parent or primary caregiver who is most familiar with the child’s daily behaviour and health status, this may include the mother, father or legal guardian. Data collection will proceed only if the child is comfortable with the presence and participation of the identified informant. The participants will be selected, If the participants are meeting the inclusion criteria of the study and following process will be followed: a. Access medical record of the child: The medical report of the children will be collected from the Indira Gandhi institute of child health, Bangalore. The blood report will be assessed. b. Assessment of Pre-existing Neurodevelopmental or Psychiatric Conditions in children: The clinical history of the child will be obtained to gather information on developmental milestones and neurodevelopmental concerns appropriate to the child’s age, as outlined in the current ICD-11. Details regarding any pre-existing, clinically diagnosed neurodevelopmental or psychiatric conditions prior to enrolment in the study will also be collected through a semi-structured questionnaires’. Children identified with such pre-existing conditions will be excluded from participation, as these conditions may act as confounding factors in the assessment of emotional, behavioural, cognitive, and clinical outcomes related to dengue and other febrile illnesses.
c. Identification of Dengue serotypes: The process for identifying the serotypes of Dengue involves initial collection and assessment of blood investigation reports from the Indira Gandhi Institute of Child Health (IGICH), Bangalore. These reports are analysed for clinical and laboratory indicators suggestive of Dengue Infection Following this preliminary evaluation. Approximately 2–3 mL of blood will be collected in a yellow-capped vacutainer from enrolled patients at IGICH and transported to the Department of Neurovirology, NIMHANS, for Dengue NS1 antigen and anti-dengue IgM testing to confirm dengue infection using virological diagnostic methods. Samples positive for dengue NS1 antigen will be further processed for dengue serotyping by multiplex real time PCR. The blood collections for serotyping will be carried out by a qualified laboratory technician or nursing officer, under the supervision of the Paediatric in-charge, during the acute phase or at the time of admission. Blood samples will be stored in a secured laboratory refrigerator at the Dept. of Neurovirology, NIMHANS, Bangalore for a maximum period of five years. After this period, samples will be processed and disposed. All serotyping investigations will be conducted free of cost, and participants or their families will not incur any expenses at any stage of the study.
d. Assessment of the severity of the Dengue: Dengue severity will be assessed using the World Health Organization (WHO) classification: dengue without warning signs, dengue with warning signs, and severe dengue. Assessment will incorporate laboratory parameters, including blood investigation results and dengue serotyping, alongside clinical indicators such as hospital stay duration, ICU requirement, and presence of haemorrhagic manifestations. This integrated approach ensures a comprehensive evaluation of disease severity. Assessment and Administration of the scales: For children: The participants will be selected based on the inclusion criteria. The assessment and administration of the scales will be done for the children with dengue and children with other fever. The assessment and administration of scales for the children will be conducted during the hospital stay, once the child is clinically stable or at the time of discharge, whichever is appropriate. The same set of scales and assessments will be re-administered at one month and three months’ post-discharge to monitor changes and follow-up outcomes over time.
Phase: II: Home visit and Follow-up As a second phase of the study, Home visit will be done for follow up after one month and three month of the post discharge from the hospital and the same assessment and the questionnaires will be administered. Another important objectives of the home visit are to identify the source of Mosquito and assess the academic performance of the child. School visit: School visit will be done to assess the number of days of schooling missed (Absenteeism) at 1 and 3 months to the school due to dengue fever and academic performance of the child. Absenteeism: In this context refers to the number of school days a child has missed, as reported by parents, at two specific follow-up intervals: one month and three months after hospitalization. This information will be collected through parental self-report and serves as an important indicator of the child’s post-hospitalization recovery and reintegration into daily life, particularly their ability to resume regular school attendance. Tracking absenteeism provides insight into the broader impact of illness or hospitalization on a child’s educational continuity and social development. It also helps identify potential needs for academic support, psychological intervention, or ongoing medical care.
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