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CTRI Number  CTRI/2017/09/009652 [Registered on: 05/09/2017] Trial Registered Prospectively
Last Modified On: 04/09/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Utility of perfusion index for diagnosis of shock in neonates 
Scientific Title of Study   Predictive value of perfusion index for diagnosis of shock in neonates 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Modi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram hospital 
Address  Department of Neonatology Sir Ganga Ram hospital Rajinder nagar New Delhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  drmanojmodi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manoj Modi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram hospital 
Address  Department of Neonatology Sir Ganga ram hospital Rajinder nagar New Delhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  drmanojmodi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manoj Modi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram hospital 
Address  Department of Neonatology Sir Ganga Ram hospital Rajinder nagar New Delhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  drmanojmodi@gmail.com  
 
Source of Monetary or Material Support  
PI Initiated trial Manoj Modi Department of Neonatology Sir Ganga Ram hospital, New Delhi 110060 
 
Primary Sponsor  
Name  Manoj Modi 
Address  Sir Ganga Ram Hospital Rajinder Nagar 
Type of Sponsor  Other [Self] 
 
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 
Manoj Modi  Sir Ganga Ram hospital  Department of Neonatology Sir Ganga Ram hospital Rajinder nagar
New Delhi
DELHI 
9873266331

drmanojmodi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonates admitted to neonatal intensive care unit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Neonates admitted to NICU for hemodynamic monitoring 
 
ExclusionCriteria 
Details  1. Perinatal asphyxia defined as 5 min APGAR <3
2. Neonates with congenital heart disease
3. Neonates with hemodynamically significant patent ductus atreriosus (PDA)
4. Neonates with a diagnosis of persistent pulmonary hypertension (PPHN)
-Neonates with gross congenital malformations
-Neonates receiving inotropes prior to admission to NICU
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
diagnosis of shock   during NICU stay 
 
Secondary Outcome  
Outcome  TimePoints 
none  NA 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/09/2017 
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   Presently under recruitment phase 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Prsent study is designed to evalaute utility of perfusion index for diagnosis of shock in neonates. In present study all neonates will be enrolled at time of admission to NICU. Demographic characteristics and antenatal details of enrolled infants, including maternal hypertension, fetal growth restriction, umbilical artery Doppler abnormality, chorioamnitis, antenatal steroid cover, and mode of delivery will be recorded on a proforma. Neonates  will be cared in thermoneutral environment, under radiant warmer/incubator, with care to prevent cold stress.

Data recording:

Neonates will be continuously monitored for clinical signs of perfusion including heart rate, BP, pulse volume, CRT, central and peripheral temperature and urine output by attending neonatal nurse.

HR and SPO2 and PI will be recorded from Masimo pulse oximetry monitor, when neonate is in quiet state. Pulse volume will be assessed by palpating radial pulse by attending neonatologist and will be categorized as good or poor pulse volume. PI will be recorded from Masimo pulse oximeters, Radical-7 display, with monitor configured for long format so as to get an average of last 5 min.

BP will be measured in right arm, by oscillometric method using dreager vista monitor, with neonate is lying supine. An appropriate sized cuff (encircling 2/3rd of the circumference of limb) will be applied, preferably to the right upper arm. The infant will then left undisturbed for at least 5 minutes, until he is quiet or asleep. Three successive BP recordings will be taken at 2-minute intervals and average of these will be taken.

CRT will be measured using electronic stop watch. An area over sternum will be pressed with index finger for 2 seconds and then released; time taken from release to refilling will be recorded.

Central and peripheral temperature will be recorded from electronic display of warmer/incubator with central probe applied over abdomen and peripheral probe applied to sole of foot.

Urine output (per kg per hour) will be calculated from diaper weight, by dividing output in preceding 2 diapers with the interval between these diaper changes.

 Blood gas analysis (through arterial puncture or an indwelling arterial catheter) will be done if a possibility of shock is considered, or for assessment of gas exchange in cardio-respiratory disorders, or at per clinician’s discretion. Blood lactate values will be noted from concurrent blood gas analysis.

 To evaluate predictive value of each hemodynamic parameter, ROC curves will be drawn and comparison of area under curve for each parameter will be done. Sensitivity, specificity, positive predictive value and negative predictive value and 95% confidence intervals for each parameters will be reported.

Definition of shock

Abnormal findings will be confirmed by attending neonatologist. Diagnosis of shock will be made if three or more of following are present:

·         Resting HR >180/min

·         Mean BP less than 10th centile for gestational age

·         CRT > 3 sec

·         Central peripheral temperature difference > 4 *C

·         Poor peripheral pulses

·         Urine output <1 ml/kg/hr (preceding 6 hrs)

·         Blood lactate >4 mmol/L

 

 
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