| CTRI Number |
CTRI/2022/07/044009 [Registered on: 14/07/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pituitary hormone profile after Brain Injury |
|
Scientific Title of Study
|
Pituitary Function Assessment after Traumatic Brain Injury in Children: A Prospective Cohort Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Department of Health Research
Ministry of Health & Family Welfare, Government of India, Ansari Nagar |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Aashima Dabas |
Maulana Azad Medical College and Lok Nayak Hospital |
Department of Pediatrics and Neurosurgery, Near Casualty Block, MAMC and LNH, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
9968694424
dr.aashimagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 3 month to 16 years
2. Hospitalized for a clinical indication like altered sensorium, seizures, amnesia, repeated vomiting, bleeding nose or Ear, skull fracture, or neurological signs after traumatic brain injury
|
|
| ExclusionCriteria |
| Details |
1. Patients who succumb within first 48 hours of hospitalization
2. Patients with pre-existing endocrinal disorder unrelated to existing illness
3. Patients with previously diagnosed static or progressive central nervous system disease (like epilepsy, brain tumor, meningoencephalitis, cerebral palsy)
4. Patients with history of consumption of drugs in the last 12 months which can affect interpretation of pituitary hormone levels (example corticosteroids, anti-epileptic drugs)
5. Patients with any major congenital anomalies (example neural tube defects) or chromosomal disorders
6. Patients who discontinue treatment before discharge
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pituitary disorders in children with traumatic brain injury |
Baseline, 6 months, 12 months, 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Association of pituitary dysfunction with the injury characteristics (severity, type, mechanism)
b. Association of pituitary dysfunction with neuronal injury biomarkers
c. Resolution of pituitary dysfunction in diagnosed cases during the study period
|
6, 12 and 24 months |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
18/07/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic brain injury is one of the common injuries seen in childhood. Apart from the immediate risk of mortality and long term neurological deficits, traumatic brain injury is also associated with early or late hypothalamic-pituitary dysfunction. The present literature shows that almost 25-45% of adults develop hypopituitarism after traumatic brain injury. Similar information is scarce in the pediatric population. Few studies with small sample size have shown transient hypopituitarism in 15-30% by 6 months which recovers in most by 12 months. However, newer pituitary deficiencies were reported in a few patients at 12 months after traumatic brain injury. The present study is proposed as a prospective cohort study to estimate the incidence of hypopituitarism in children with traumatic brain injury. All children aged 3 months to below 18 years who will be hospitalized for a clinical indication after a traumatic brain injury will be enrolled. Children with a pre-existing endocrine disorder, central nervous system disorder, major congenital malformations or with the intake of drugs in last 12 months which can interfere with hormonal estimation will be excluded. Assuming the proportion of children with hypopituitarism at 12 months as 7.33% from an earlier study, confidence limits (d)= 0.1 and alpha error as 5%, a total of 104 subjects will be needed. Accounting for 10% lost to follow-up, the total sample of 115 children will be enrolled. The baseline clinical details of enrolled subjects will be recorded. Markers of neuronal inflammation will be recorded in the blood. Endocrinal evaluation at baseline for water and electrolyte disturbances, and function of thyroid axis, cortisol axis, prolactin, growth axis, and sex-hormones will be done. Those who are detected with any abnormality will be treated as per standard protocol. The children who are discharged will be followed-up at three monthly intervals for clinical monitoring. They will be subjected to laboratory estimation of pituitary hormonal profile over a period of two years at 6, 12 and 24 months. The incidence and time-to event for hypopituitarism will be recorded. The proportion of hypopituitarism with severity of brain injury and type of brain injury will also be evaluated. The natural course of hypopituitarism during the study period will be noted. |