| CTRI Number |
CTRI/2024/09/073586 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of a hormone to reduce giving blood traansfusion in less than 1 kg newborns |
|
Scientific Title of Study
|
Use of Erythropoetin in reducing blood tranfusion in Extremely Low Birth Weight neonates: A Prospective Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha Ananthan |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology, New building, 10th floor
Department of Neonatology
ward 38
10th floor
KEM Hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amruta Amte |
| Designation |
Senior resident |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology, New building, 10th floor
Department of Neonatology
ward 38
10th floor
KEM Hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
amruta.amte.aa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anitha Ananthan |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology, New building, 10th floor
Department of Neonatology
ward 38
10th floor
KEM Hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology, Seth GS Medical College and KEM Hospital, Acharya Donde Marg
Parel-400012 |
| 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 Anitha Ananthan |
KEM Hospital |
New building 10th floor
Seth GS Medical College and KEM Hospital, Acharya Donde Marg
Parel-400012
Mumbai
MAHARASHTRA |
9769660870
ani.gem81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitionsl Ethics Committee-II Relating to Biomedical And Health Research |
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 |
Inj Erythropoietin |
Inj erythropoietin is started at birth at 400 IU/kg/dose thrice a week up to 35 weeks of postmenstrual age. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants less than 28 weeks of gestation and/or & birth weight less than 1000 gms |
|
| ExclusionCriteria |
| Details |
Any known hematological disorders and hemoglobinopathies
Hydrops fetalis
Critical Congenital Heart Disease
Life threatening gross congenital anomalies
Any intrauterine transfusion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
need for more than 1 blood transfusion in
extremely low birth weight infants. |
60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The total volume (mL/kg or mL/kg/day) of RBCs transfused per infant. |
60 days |
| Number of Blood transfusion per infant. |
60 days |
| Mortality during initial hospital stay (all causes). |
28 days |
Retinopathy of prematurity (ROP) (any stage and stage 3 or more)
|
60 days |
Proven sepsis (clinical symptoms and signs of sepsis and positive blood
culture for bacteria or fungi). |
60 days |
| Necrotizing enterocolitis |
28 days |
| Intraventricular haemorrhage all grades |
28 days |
| Periventricular leukomalacia |
60 days |
| Length of hospital stay |
60 days |
| Bronchopulmonary dysplasia |
60 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/10/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Extremely low-birth-weight neonates (ELBW <1 Kg) comprise less than 1% of all births. Their survival rate varies between 11% to 67% in India.This increase in survival has led to an increase in blood transfusions (BT) with up to 70% requiring more than one BT. These blood transfusions increase the risk of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP). In ELBW infants, hemoglobin falls to levels below 7.0 to 10.0 g/dL by four to 6 weeks of life and is called ’anemia of prematurity’ (AOP), which increases the need for BT. Erythropoietin (EPO) is a glycoprotein hormone, produced by the peritubular cells of the kidney, that stimulates RBC production and plays a vital role in the pathogenesis of AOP. Low EPO levels in ELBW neonates thus provide a rationale for its use in the prevention and treatment of AOP. The Cochrane review comprised of 27 studies with 2209 infants have extensively studied the role of erythropoietin in the prevention of AOP and have concluded that early erythropoietin (< 7 days) reduced the risk of the ’use of one or more BT (typical risk ratio (RR) 0.79, 95% confidence interval (CI) 0.73 to 0.85). Further comparison of early vs late EPO and low dose ( <500 units/kg/week) vs high dose EPO (>500 units/kg/week) was analysed in the Cochrane review (6,7) and showed that the use of early and high dose EPO did not significantly reduce the ’use of one or more BT or the ’number of BT per infant" compared with late or low dose EPO administration. Most of these trials which contributed to Cochrane review were conducted in high and middle-income trials and they had non-uniformity in BT practice. A prospective observational study from Indian sub-continent has used late and high dose EPO (600 IU weekly till discharge) and found reduction in blood transfusion rate in ELBW infants (9). There is lacunae in literature from the Indian subcontinent about the effectiveness of early and high dose EPO. Hence, we plan to conduct this study to assess the effect of erythropoietin in the prevention of >1 blood transfusion in ELBWs infant and study its effect on short term outcomes of the preterm neonate. We hypothesise that the use of EPO in ELBW babies will lead to a decrease in the need of blood transfusion.
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