| CTRI Number |
CTRI/2017/07/009104 [Registered on: 26/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Normal values of cerebral blood flow velocities in stable infants less than 1500 g during first month of life. |
|
Scientific Title of Study
|
Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharat Kansal |
| Designation |
MBBS MD |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar
New Delhi Dept Of Neonatology
Sir Gangaram hospital
Old Rajender Nagar
New Delhi-110060 New Delhi DELHI 110060 India |
| Phone |
9742336747 |
| Fax |
|
| Email |
drbharatkansal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anup Thakur |
| Designation |
MBBS MD DNB (Neonatology) |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar
New Delhi Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar
New Delhi New Delhi DELHI 110060 India |
| Phone |
8800565956 |
| Fax |
|
| Email |
dr.thakuranup@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anup Thakur |
| Designation |
MBBS MD DNB (Neonatology) |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar
New Delhi Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar
New Delhi New Delhi DELHI 110060 India |
| Phone |
8800565956 |
| Fax |
|
| Email |
dr.thakuranup@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Gangaram Hospital |
| Address |
Department of Neonatology
Sir Gangaram hospital
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bharat Kansal |
Sir Gangaram Hospital |
Department of Neonatology, Sir Gangaram Hospital
Old Rajender Nagar- New Delhi -110060 New Delhi DELHI |
9742336747
drbharatkansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Gangaram hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P019||Newborn affected by maternal complication of pregnancy, unspecified, Stable babies with birth weight less than 1500gms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All infants less than 1500 gram who are hemodynamically stable, defined as having a resting HR between 120 and 180 per min, SPO2 >85%, CFT <3 sec and mean BP above 10th centile for gestation specific normogram. |
|
| ExclusionCriteria |
| Details |
1) Infants with gross congenital malformations.
2) Infants requiring extensive resuscitation-chest compression or medications at birth.
3) Infants on mechanical ventilation with mean airway pressure (MAP) >12 mbar.
4) Infants requiring inotropes.
5) Infants with intraventricular hemorrhage of Grade II or higher (Papile classification) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure Cerebral blood velocities of Anterior cerebral, Middle cerebral and basilar arteries |
2-8 hours of life
24 hours,3 days,7 days,14 days and 28 days/ or at the time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
14/07/2017 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title- Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life. Very Low Birth Weight (VLBW) infants undergo a dramatic change in hemodynamics during transition in the early neonatal period. Knowledge of postnatal age specific normative data on cerebral blood flow during first few weeks of life might be valuable and may help in early identification of abnormal adaptation. Besides this, cerebral blood flow changes can be detected before clinical decompensation of circulatory response occurs. However before attempting to interpret changes in acute diseased states, it is imperative to understand normal changes in cerebral blood flow in neonates. Longitudinal data on changing cerebral hemodynamics after birth are still lacking. There is a need to define gestation specific longitudinal data on cerebral blood flow indices in hemodynamically stable VLBW infants. We plan to conduct an observational study to determine normative values of cerebral blood flow velocities in anterior cerebral artery, middle cerebral artery and basilar artery in stable VLBW infants in the first month of life (at 2-8 hours, 24 hours, 3 days, 7 days, 14 days and 28 days or at the time of discharge). |