| CTRI Number |
CTRI/2020/01/022964 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial on the effect of reducing blood sampling in extremely preterm neonates |
|
Scientific Title of Study
|
Effect of limiting blood sampling losses in early postnatal period in extremely premature neonates- A Randomized controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vimmi Tripathi |
| Designation |
IAP Fellow in Neonatology(Senior resident) |
| Affiliation |
Surya childrens medicare pvt. ltd. |
| Address |
SURYA HOSPITAL,Department of Neonatology
NEW BLOCK, 4th floor,S V ROAD, SANTACRUZ WEST
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
09819409614 |
| Fax |
|
| Email |
vimmitripathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haribalakrishna Balasubramanian |
| Designation |
Consultant Neonatologist (Guide) |
| Affiliation |
Surya childrens medicare pvt. ltd. |
| Address |
SURYA HOSPITAL,Department of Neonatology.
NEW BLOCK, 4th floor,S V ROAD, SANTACRUZ WEST
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
09820457078 |
| Fax |
|
| Email |
doctorhbk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimmi Tripathi |
| Designation |
IAP Fellow in Neonatology(Senior resident) |
| Affiliation |
Surya childrens medicare pvt. ltd. |
| Address |
SURYA HOSPITAL,Department of Neonatology
NEW BLOCK, 4th floor,S V ROAD, SANTACRUZ WEST
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
09819409614 |
| Fax |
|
| Email |
vimmitripathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surya Childrens Medicare private ltd |
|
|
Primary Sponsor
|
| Name |
Surya Hospital |
| Address |
S.V.Road
Santacruz west
Mumbai |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Surya Children medicare pvt ltd |
S.V.Road
Santacruz west
Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Vimmi Tripathi |
Surya Hospital |
Department of Neonatology,4th floor,new block,S V Road,Santacruz west
Mumbai (Suburban)
MAHARASHTRA |
09819409614
vimmitripathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Childrens medicare private limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P070||Extremely low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Limited blood sampling group |
Three pronged approach to limit blood sampling losses in first 1 month of life,by
A-Reducing frequency of sampling
B-Reducing volume of blood sampled
C-Delaying certain blood investigations to beyond 1 month of postnatal age. |
| Comparator Agent |
Standard blood sampling group |
Blood sampling as per standard unit protocol for extremely premature neonates. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants ≤ 28 weeks of gestation and
≤ 1 kg birth weight,enrolled at 12-24 hours of postnatal age.
|
|
| ExclusionCriteria |
| Details |
1.Placenta previa, Abruptio placentae, Retroplacental hemorrhage (Concealed hemorrhage)
2.Monochorionic twins/triplets/Quadruplets
3.Rh isoimmunisation
4.Hydrops fetalis
5. Major congenital anomalies in the infant like Gastroschisis, Exomphalos.
6. Extremely sick neonates who are deemed unlikely to survive beyond first 72 hours of life.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for Packed RBC transfusions |
At 6 weeks of postnatal age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for packed RBC transfusion
|
At the time of discharge |
| Time to first packed RBC transfusion |
At the time of discharge |
Number of transfusions
|
At the time of discharge |
Phlebotomy loss volume
|
At the time of discharge |
Weekly hemoglobin level
|
At the time of discharge |
All cause mortality
|
At the time of discharge |
| severe Intraventricular haemorrhage(Grade 3 or 4) |
At the time of discharge |
Patent ductus arteriosus requiring treatment
|
At the time of discharge |
Late onset sepsis ( culture positive)
|
At the time of discharge |
Necrotising enterocolitis (stage 2 or more)
|
At the time of discharge |
Bronchopulmonary Dysplasia(Oxygen requirement at 36 weeks)
|
At the time of discharge |
Retinopathy of prematurity requiring intervention.
|
At the time of discharge |
| Periventricular Leukomalacia |
At the time of discharge |
Time to reach full feeds
|
At the time of discharge |
Duration of respiratory support (days)
|
At the time of discharge |
Duration of hospital stay (days)
|
At the time of discharge |
Neurodevelopmental outcomes
|
At 18-24 months of corrected gestational age |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2020 |
| Date of Study Completion (India) |
02/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary purpose of the study is to (a) assess the feasibility of limited blood sampling approach,(b) determine the effect of limiting phlebotomies on transfusion requirements in extremely premature neonates.Our hypothesis is that a limited blood sampling approach would result in a significant reduction in the proportion of neonates requiring packed RBC transfusions in the first 6 weeks of postnatal age . Eligible neonates will be stratified for gestational age and the primary outcome estimates would be adjusted for gestational age and haemoglobin at admission. Interim analysis for safety would be performed after 50% enrolment in the study. |