| CTRI Number |
CTRI/2020/04/024589 [Registered on: 13/04/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of Red Blood Cell Distribution Width to predict clinical outcomes in children admitted in Pediatric Intensive Care Unit. |
|
Scientific Title of Study
|
RED BLOOD CELL DISTRIBUTION WIDTH AS PREDICTOR OF CLINICAL OUTCOMES IN CHILDREN ADMITTED IN PEDIATRIC INTENSIVE CARE UNIT. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana Dogra |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9555041577 |
| Fax |
|
| Email |
anjanadogra5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urmila Jhamb |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9968604309 |
| Fax |
|
| Email |
ujhamb@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urmila Jhamb |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9968604309 |
| Fax |
|
| Email |
ujhamb@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Maulana Azad Medical College and associated Lok Nayak hospital, Bahardur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjana Dogra |
Maulana Azad Medical College and associated Lok Nayak hospital |
Department of Pediatrics,
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI |
9555041577
anjanadogra5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All the children 1 month to 12 years of age admitted in Pediatric Intensive Care Unit. |
|
| ExclusionCriteria |
| Details |
1. Children with malignancies including hematological malignancies.
2. Blood transfusion in last 3 months.
3. Patients on anti epileptic drugs.
4. Those who were admitted after Cardio-Pulmonary Resuscitation.
5. Patients admitted for routine short term planned post-operative care.
6. Patients with more than one PICU admission during the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Day 1 Red blood cell distribution width as predictor of all cause mortality in children admitted to Pediatric Intensive Care Unit. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Day 1 Red blood cell distribution width as prognostic marker for organ failure(Pediatric Logistic Organ Dysfunction score), Duration of ventilation days, Length of stay.
2.Highest recorded Red blood cell distribution width association with mortality and morbidity.
3.Association of Day 1 Red blood cell distribution width with abnormal vital
parameters and severity of illness (PRISM III score). |
7 days |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
16/04/2020 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational study to study the association of Red blood cell distribution width with mortality and morbidity in children admitted in Pediatric Intensive Care Unit. The primary outcome will be association of day 1 red blood cell distribution width with all cause mortality in children admitted to pediatric intensive care unit. The secondary outcomes will be association of day 1 red blood cell distribution width with organ failure, duration of ventilation days, length of stay, abnormal vital parameters, severity of illness and association of highest recorded red blood cell distribution width with mortality and morbidity. |