| CTRI Number |
CTRI/2020/08/027185 [Registered on: 17/08/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of adrenaline and noradrenaline for neonates with septic shock |
|
Scientific Title of Study
|
Adrenaline Vs Noradrenaline in neonatal septic shock:A randomised 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 |
Reema A Garegrat |
| Designation |
Dm neonatology Resident |
| Affiliation |
Bharati Vidyapeeth,Pune |
| Address |
Nicu level 3,second floor,department of neonatology ,Bharati Vidyapeeth hospital and research centre,Katraj ,Pune -411043
Pune
MAHARASHTRA
400050
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
coolreem18@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Suryawanshi |
| Designation |
Head of Department ,Neonatology |
| Affiliation |
Bharati Vidyapeeth,Pune |
| Address |
Second floor,NICU level 3,Department of Neonatology ,Bharati Vidyapeeth hospital campus
Pune
MAHARASHTRA
411043
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reema A Garegrat |
| Designation |
Dm neonatology Resident |
| Affiliation |
Bharati Vidyapeeth,Pune |
| Address |
Department of neonatology ,second floor,nicu level 3,Bharati Vidyapeeth hospital
Pune
MAHARASHTRA
411043
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
coolreem18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth hospital and research centre,Pune -411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth hospital |
| Address |
Bharati Vidyapeeth hospital and research centre
Katraj Pune |
| Type of Sponsor |
Private 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 |
| Reema garegrat |
Bharati Vidyapeeth hospital and research centre |
Nicu level 3,second floor,department of neonatology
Hospital building
Pune
MAHARASHTRA |
9819588972
coolreem18@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R578||Other shock, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adrenaline |
After fluid resuscitation some neonates for septic shock will receive adrenaline as per randomisation table started with 0.1 microgram per kg and graded up til 1 microgram
And infused via peripheral intravenous catheter or central line |
| Intervention |
Noradrenaline |
After fluid resuscitation is completed neonates with septic shock will receive noradrenaline as per the randomisation table dose being 0.2 microgram per kg,can be given via peripheral intravenous catheter or central line and tapered after resolution of shock |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates (<28 days) with diagnosis of septic shock.
Shock was defined by systemic hypotension (mean blood pressure <10th percentile of the normal range for birth weight [BW] and postnatal age) with at least three of the following criteria for decreased perfusion:
(i) Tachycardia (heart rate > 20 above baseline )
(ii) Peripheral pulses
(iii) Modified extremities colouration
(iv) Prolonged capillary refill time >3 sec and;
(v) Urine output <1 mL/kg/h |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1. Response at 1 hour (Resolved/Unresolved)
Resolution of shock will be defined at 1 hour as
a) Systolic Blood pressure (SBP) as well as Diastolic Blood Pressure (DBP) 5th centile.
b) Capillary Refill Time (CFT) 3 s
2. Mortality: Incidence of mortality in both groups |
1 hour for resolution of shock
Mortality at discharge from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Requirement of additional vasopressors.2. Hemodynamic stability requiring no further escalation of vasopressors for a period of ≥ 120 min
3. Vitals (HR, SBP, DBP and MAP) and acid-base parameters
4. Incidence of Complications until discharge i.e.
a) Intraventricular Hemorrhage (IVH):
b) PVL (Periventricular Leukomalacia)
c) Acute Kidney Injury (AKI)
d). Necrotizing Enterocolitis (NEC) stage II/ III:
e) Duration of days of ventilation |
Abg at 0 and 60 ‘mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2020 |
| Date of Study Completion (India) |
31/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of this study to compare adrenaline versus noradrenaline in the shock management of neonates as there is paucity of data regarding the same
|