| CTRI Number |
CTRI/2019/03/018089 [Registered on: 14/03/2019] Trial Registered Prospectively |
| Last Modified On: |
28/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Monitoring of Cerebral oxygen saturation in preterm and very preterm infants diagnosed with Retinopathy of prematurity during Vitreo retinal surgeries using Near Infra Red Spectroscopy and Assessment of risk factors for Low cerebral oxygen saturation: An observational prospective study |
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Scientific Title of Study
|
Intra operative monitoring of cerebral oxygen saturation using Near Infra Red Spectroscopy (NIRS) and Assessment of risk factors for Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity during Vitreo retinal surgeries:An observational prospective study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARYA PRASAD S R |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences New Delhi |
| Address |
Department Of Anaesthesiology Pain medicine and Critical Care
All India Institute Of Medical Sciences
New Delhi
Aramam Kottakkakom Perinadu PO Kollam Kerala 691601
South West
DELHI
110029
India |
| Phone |
8129044239 |
| Fax |
|
| Email |
aryaprasadsr1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DILIP R SHENDE |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences New Delhi |
| Address |
Department of Anaesthesiology Pain medicine and Critical Care
All India Institute Of Medical Sciences New Delhi
South West
DELHI
110029
India |
| Phone |
8800377697 |
| Fax |
|
| Email |
dilipshende@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DILIP R SHENDE |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences New Delhi |
| Address |
Department of Anaesthesiology Pain medicine and Critical Care
All India Institute Of Medical Sciences New Delhi
South West
DELHI
110029
India |
| Phone |
8800377697 |
| Fax |
|
| Email |
dilipshende@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Rajendra Prasad Centre for Ophthalmic Sciences
Department of Anaesthesiology,Pain medicine and Critical Care
All India Institute Of Medical Sciences
New Delhi |
|
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Primary Sponsor
|
| Name |
HEAD OF THE DEPARTMENT |
| Address |
Department of Anaesthesilogy Pain medicine and Critical Care
All India Institute Of Medical Sciences
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDILIP R SHENDE |
Dr.Rajendra Prasad Centre for Ophthalmic Sciences |
4TH FLOOR
Dr.Rajendra Prasad Centre for Ophthalmology
Department of Anaesthesilogy Pain medicine and Critical Care
All India Institute Of Medical Sciences
New Delhi
South West
DELHI |
8800377697
dilipshende@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH FOR CLINICAL SCIENCE All India Institute Of Medical Sciences New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, (2) ICD-10 Condition: P09||Abnormal findings on neonatal screening, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
1.Preterm and very preterm infants with post conceptional age of 31 to 60 weeks or up to 6 months of age with Retinopathy of prematurity posted for elective Vitreo retinal surgery
2.Infants uptown 5kg weight
3.Including single and both eye Video retinal surgeries
4.Duration of surgery more than half an hour
5.Patients with mild congenital heart disease such as mild PS,mild AS,VSD can be included in this study.
4. |
|
| ExclusionCriteria |
| Details |
1.Patient parental refusal for consent
2.Associated moderate-severe congenital heart disease involving major cardio vascular shunting
3.Diagnosed with any neurological disease of brain
4.Associated structural malformations of frontal brain or scalp or skull by history or physical examination
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of low cerebral oxygen saturation (mild-severe) in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgery |
1.Mild-relative decrease in rScO2 of 11-20% from baseline value or absolute rScO2 60-69% for more than 3 minute
2.Moderate -decrease of 21-30% from baseline value or absolute value 50-55% for more than 3 minutes
3.Severe-relative decrease in rScO2 greater than 30% below baseline or absolute value less than 50% for more than 3 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To describe differences in regional cerebral oxygen saturation (rScO2) during different timelines of anaesthesia such as induction,during surgery and extubation |
1.Baseline-time between placement of NIRS probe on patients forehead before induction of anesthesia and administration of anaesthetic drugs or supplemental oxygen to induce anesthesia
2.Induction time-time from administration of anesthetic induction drugs to the start of surgery
3.Surgery time-time from start of incision until the last stitch or dressing to be placed
4.Emergence time-time from 3-5minutes after the last stitch or dressing being placed till extubation of child |
| To identify factors associated with Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgery |
1.Preterm-babies born alive before 37 weeks of gestational age
Late preterm-32 to 37weeks
Very preterm-28-32weeks
Extremely pretty-less than 28weeks
2.Staging of Rop according to international classification
3.Hypotension lasting for 3 minutes
Mild-MAP of 36-45mmHg or systolic Bp 51-60mmHg
Moderate-MAP of 26-35mmHg or systolic Bp 41-50mmHg
Severe-MAP of less than 25mmHg or systolic Bp less than 40mmHg |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2019 |
| Date of Study Completion (India) |
28/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Intra operative monitoring of cerebral oxygen saturation using Near Infra Red Spectroscopy (NIRS) and assessment of risk factors for Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity during Vitreo retinal surgeries:An observational prospective study will be conducting in 50 preterm and very preterm infants upto 6months of age with retinopathy of prematurity who are posted for elective Vitreo retinal surgeries to find out the indicence of Low cerebral oxygen saturation in these infants and to describe the differences in regional cerebral oxygen saturation during different time lines of anesthesia using Near Infra Red Spectroscopy and also to identify factors associated with low cerebral oxygen saturation in these patients. Study will be conducting at Dr.Rajendra Prasad Center for Ophthalmic Sciences,AIIMS New Delhi under Department of Anaesthesilogy Pain medicine and Critical Care,AIIMS New Delhi. |