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CTRI Number  CTRI/2024/10/074892 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Early hydrocortisone in neonatal shock in neonates with shock on single inotrope and to assess the duration of inotrope requirement post hydrocortisone 
Scientific Title of Study   Early hydrocortisone in neonatal shock versus standard care,a randomized 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  Dr PRIYANKA RM 
Designation  PEDIATRIC MEDICINE RESIDENT 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  First floor,department of neonatology,Indira Gandhi Institute of Child Health ,1st Block, Siddapura, Jayanagar, Bengaluru, Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  7795491089  
Fax    
Email  PRYNK.R1@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  Dr PRATHIK BH 
Designation  NEONATOLOGIST 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  First floor,department of neonatology,indira gandhi institute of child health ,1st Block, Siddapura, Jayanagar, Bengaluru, Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  9717235721  
Fax    
Email  Prathikbh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr NIRANJAN HS 
Designation  PROFESSOR 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  First floor,department of neonatology,Indira Gandhi institute of child health ,1st Block, Siddapura, Jayanagar, Bengaluru, Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  7795491089  
Fax    
Email  drniranjan_hs@yahoo.com  
 
Source of Monetary or Material Support  
Neonatology department. NICU - First floor Indiragandhi Institute Of ChildHealth, Bangalore. 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Child Health 
Address  First floor,Department of Neonatology,Indira Gandhi Institute of Child Health ,1st Block, Siddapura, Jayanagar, Bengaluru, Karnataka 560029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priyanka R M  indiragandhi institute of child health  First floor,Department of Neonatology ,Indira Gandhi Institute of Child health 1st Block, Siddapura, Jayanagar, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA 		 7795491089

Prynk.r1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IGICH ECC  Approved 
Institutional ethics Committee igich bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R57||Shock, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Neonates randomized to the control group received standard care for shock as per unit protocol. The protocol for management of shock was similar in both the groups except for the study drug. Standard care of neonatal shock according to unit policy is defined as below: Step 1 : Crystalloid administered,Infusion of isotonic normal saline 10 ml/kg upto 60 ml/kg Step 2: Dopamine or Dobutamine started at 5mcg/kg/min and increased by 2.5mcg/kg/min every 5 min upto 20mcg/kg/min Step 3: Second inotrope : Noradrenaline :0.1mcg/kg/min upto 3mcg/kg/min Step 4: Hydrocortisone 1 mg/kg given every 8 hours  
Intervention  Early Hydrocortisone in neonatal shock  After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. Neonates fulfilling all the inclusion criteria and none of the exclusion criteria will be included in the study .Enrolled Neonates will be randomized into the study once they have been started on Dopamine 10mcg/kg/min ,depending upon the type of hypotension .Neonates randomized to study group will receive 0.5mg/kg hydrocortisone every 12 hours for 48 hours .Neonates randomized to control group will receive standard care of neonatal shock . Serum cortisol levels estimated before initiation of hydrocortisone .2ml of Venous blood will be collected under aseptic precautions and serum cortisol level measured using electrochemiluminescence immunoassay (ECLIA) method in Cobas e analyzer. Neonates in both groups will be monitored Serially,vital parameters will be recorded hourly till resolution of shock occurs .Arterial blood gas analysis will be done as per clinical indication .Urine output will be assessed every 6 hourly .Further management of neonates done as per unit policy. Randomization sequencing will be generated using computer based sequencing and allocation concealment done by storage in serially numbered opaque envelopes. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1)Patient attenders willing to give informed consent
2)Neonates (age <28 days ) taken into consideration for study  
3)Gestational age of  28 weeks to 40 weeks
4)Should fulfill criteria for neonatal shock
Clinical features suggestive of shock:  
Symptoms of decreased peripheral perfusion :Cold,pale skin with delayed capillary refill time
,tachycardia,weak peripheral pulses,Narrow pulse pressure,oliguria
Hypotension : MAP <30 mmHg (MEAN ARTERIAL PRESSURE) or
MAP < neonate’s gestational age in weeks at time of birth or
BP less than fifth centile for gestational age
5) Maximum dose of dopamine 10 mcg/kg/min reached 
 
ExclusionCriteria 
Details  1)Patient attenders not willing to give informed consent
2) Neonates with suspected Congenital adrenal hyperplasia
3) Major life threatening congenital malformations
4) Indomethacin usage for treatment of PDA
5) Suspected or proven NEC
6) Hypovolemic shock
7) Obstructive shock 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)improvement in shock measured in terms of following parameters
A) MAP-mean arterial pressure that lies between 50-90th centile
2)CFT (CAPILLARY REFILL TIME ) less than three seconds
3)Urine output more than 1ml per kg per hour
 		 At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1)Need for 2nd inotrope
2)Assess Baseline serum cortisol levels
3)Incidence of hyperglycemia,hypertension,
4)Incidence of SIPS (SPONTANEOUS INTESTINAL PERFORATION ) ,NEC (NECROTIZING ENTEROCOLITIS ),Death
5)Duration of hospital stay
6)Incidence of culture positive sepsis
 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
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="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 15-08-2022 and end date provided 15-03-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

PRIMARY OBJECTIVE : To study the effectiveness of Early hydrocortisone in Neonatal shock

SECONDARY OBJECTIVE: To assess baseline serum cortisol levels in neonatal shock

 Source of data: INPATIENTS ADMITTED TO NICU , INDIRA GANDHI INSTITUTE OF

CHILD HEALTH

A. Study design:

Interventional : Prospective Randomized  control trial

B. Study period:  1.5 years

C. Place of study : NICU ,INDIRA GANDHI INSTITUTE OF CHILD HEALTH

Total sample size 60 (30 in each group )

METHODOLOGY:

After obtaining approval and clearance from the institutional ethics committee, the patients

fulfilling the inclusion criteria will be enrolled for the study after obtaining informed

consent. Neonates fulfilling all the inclusion criteria and none of the exclusion criteria will be

included in the study .Enrolled Neonates will be randomized into the study once they have been

started on Dopamine 10mcg/kg/min ,depending upon the type of hypotension .Neonates

randomized to study group will receive 0.5mg/kg hydrocortisone every 12 hours for 48 hours

.Neonates randomized to control group will receive standard care of neonatal shock . Serum

cortisol levels estimated before initiation of hydrocortisone .2ml of Venous blood will be

collected under aseptic precautions and serum cortisol level measured using

electrochemiluminescence immunoassay (ECLIA) method in Cobas e analyzer.

Neonates in both groups will be monitored Serially,v ital parameters will be recorded hourly till

resolution of shock occurs .Arterial blood gas analysis will be done as per clinical indication .Urine

output will be assessed every 6 hourly .Further management of neonates done as per unit policy.

Randomization sequencing will be generated using computer based sequencing and allocation

concealment done by storage in serially numbered opaque envelopes.

Study end point :Till discharge /death

Primary outcome :

1)Improvement of shock

2)Duration of inotropes requirement

 

Secondary outcome :

1)Need for 2nd inotrope

2)Assess Baseline serum cortisol levels

3)Incidence of hyperglycemia,hypertension,

4)Incidence of SIPS (SPONTANEOUS INTESTINAL PERFORATION ) ,NEC (NECROTIZING

ENTEROCOLITIS ),Death

5)Duration of hospital stay

6)Incidence of culture positive sepsis


 
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