| CTRI Number |
CTRI/2024/06/069595 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Efficacy of noradrenaline vs dopamine in septic shock
Preterm babies.: open label randomised control trial
|
|
Scientific Title of Study
|
Efficacy of noradrenaline vs dopamine in septic shock with late onset sepsis in
Preterm babies.: open label randomised control trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Kanhu Deodhe |
| Designation |
Senior resident in neonatology |
| Affiliation |
Government medical college, Aurangabad. |
| Address |
Department of neonatology ,government medical college, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7038050903 |
| Fax |
|
| Email |
drvarshamore95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Joshi |
| Designation |
Associate Professor in neonatology |
| Affiliation |
Government medical college, Aurangabad. |
| Address |
Department of neonatology ,government medical college, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9823900641 |
| Fax |
|
| Email |
dramolkj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Kanhu Deodhe |
| Designation |
Senior resident in neonatology |
| Affiliation |
Government medical college, Aurangabad. |
| Address |
Department of neonatology ,government medical college, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7038050903 |
| Fax |
|
| Email |
drvarshamore95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college,Aurangabad pin code 431001 state-Maharashtra country india |
|
|
Primary Sponsor
|
| Name |
Government Medical CollegeAurangabad |
| Address |
Department of Neonatology, Government Medical college,Aurangabad pin code-431001.state maharashtra contry india |
| 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 Varsha Deodhe |
Government Medical college ,Aurangabad |
Department of Neonatology
overnment Medical college Aurangabad
Aurangabad
MAHARASHTRA |
7038050903
drvarshamore95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE Pharma/IEC-GMCA/195/2024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P299||Cardiovascular disorder originating in the perinatal period, unspecified, (2) ICD-10 Condition: P299||Cardiovascular disorder originating in the perinatal period, unspecified, (3) ICD-10 Condition: P299||Cardiovascular disorder originating in the perinatal period, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dopamine |
This group will receive dopamine intravenous infusion in a dose of 5-15 mcg/kg/min .
inotrope will be escalated every 30 minutes till adequate response
|
| Intervention |
Noradrenaline |
This group will receive noradrenaline Intravenous infusion in a dose of 0.1-0.3 mcg/kg/min
intravenous route
Inotrope will be escalated every 30 mins till response. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates less than 37 weeks with suspected late onset sepsis.
|
|
| ExclusionCriteria |
| Details |
1.Congenital structural heart disease
2.Neonate who is already on inotropes before eligibility
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recovery from shock and duration of inotrope requirement .
time duaration for normalisation of clinical parameters and echocardiographic parameters.
|
one year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality in both groups |
one year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/07/2024 |
| 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
|
Preterm neonates have lower levels of NE and dopamine immediately after birth than full-term neonates. While dopamine acts mainly through the release of NE from presynaptic vesicles, it’s effectiveness can succumb to the depletion of endogenous NE and an increased ratio of pulmonary and systemic artery pressure at high dopamine doses.Administration of dopamine at initial dosages lower than commonly recommended, followed by incremental increase in dose, may be associated with improved left ventricular performance with avoidance of undesirable tachycardia and arrhythmias.This evidence supports the trial of NE in preterm neonates with compromised hemodynamics.. Noradrenaline causes significant improvement in fractional shortening and mean bold pressure.hemodynamics. Noradrenaline is a relatively safe and effective drug to use in the treatment of neonatal septic shock.Therefore to see the effect of norepinephrine in septic shock in preterm neonates and to compare those with dopamine study this will be caried out.
|