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CTRI Number  CTRI/2022/01/039613 [Registered on: 20/01/2022] Trial Registered Prospectively
Last Modified On: 21/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   BREAST MILK FOR PAIN RELIEF DURING ECHOCARDIOGRAPHY IN NEONATES 
Scientific Title of Study   STUDY OF BREAST MILK FOR PAIN RELIEF DURING TARGETED NEONATAL ECHOCARDIOGRAPHY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PRAMEETA R CHIGARI 
Designation  IAP FELLOW IN NEONATOLOGY 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF NEONATOLOGY LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL SION WEST MUMBAI,400022

Mumbai
MAHARASHTRA
400022
India 
Phone  8904848504  
Fax    
Email  drpramitarc1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SWATI MANERKAR 
Designation  HEAD OF DEPARTMENT 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF NEONATOLOGY LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL SION WEST MUMBAI,400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9769997968  
Fax    
Email  drswatimanerkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAMEETA R CHIGARI 
Designation  IAP FELLOW IN NEONATOLOGY 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF NEONATOLOGY LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL SION WEST MUMBAI,400022

Mumbai
MAHARASHTRA
400022
India 
Phone  8904848504  
Fax    
Email  drpramitarc1@gmail.com  
 
Source of Monetary or Material Support  
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL,MUMBAI 
 
Primary Sponsor  
Name  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITALMUMBAI 
Address  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION,MUMBAI,MAHARASHTRA 400022 
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 
DR SWATI MANERKAR  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL  DEPARTMENT OF NEONATOLOGY,ROOM NO 123,FIRST FLOOR,COLLEGE BUILDING,LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL,MUMBAI
Mumbai
MAHARASHTRA 		 9769997968

drswatimanerkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LOKMANYA TILAK MUNICIPAL COLLEGE AND GENERAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EXPRESSED BREAST MILK  NEONATES UNDERGOING TARGETED NEONATAL ECHOCARDIOGRAPHY WILL BE RANDOMISED TO INTERVENTIONAL GROUP AND COMPARATOR GROUP. BABIES RANDOMISED TO INTERVENTION GROUP WILL RECEIVE 1ML/KG OF EXPRESSED BREAST MILK WHICH WILL BE SWABBED OVER THE BUCCAL MUCOSA 10 MINUTES PRIOR TO UNDERGOING ECHOCARDIOGRAPHY. 
Comparator Agent  NO INTERVENTION  NO INTERVENTION 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All VLBW babies undergoing Tn-ECHO according to NICU protocol.All VLBW babies undergoing Tn-ECHO according to NICU protocol. 
 
ExclusionCriteria 
Details  1. Severe perinatal asphyxia
2. Neonatal encephalopathy
3. Major congenital malformation
4. Babies on drugs causing CNS depression
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of PIPP-R scores between the two study group  Comparison of PIPP-R scores between the two study groups 5 minutes before, during and 5 minutes after echocardiography 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate  Comparison of heart rate between the two study groups 5 minutes before, during and 5 minutes after echocardiography 
Respiratory rate  Comparison of respiratory rate between the two study groups 5 minutes before, during and 5 minutes after echocardiography 
Blood pressure  Comparison of blood pressure between the two study groups 5 minutes before and 5 minutes after echocardiography 
Perfusion index  Comparison of perfusion index between the two study groups 5 minutes before, during and 5 minutes after echocardiography 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   25/01/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This randomised controlled trial will be conducted on VLBW babies admitted in our unit & undergoing Tn-ECHO. The study will commence after approval from Institutional Ethics Committee (IEC).

 

The decision to do Tn-ECHO will be taken by the NICU team, according to institution protocols based on the the standard of care. Those babies satisfying the inclusion criteria will be enrolled after written informed consent from either parent. Babies will be randomized to receive either expressed breast milk (Group A) or no intervention (Group B). Blocked randomization will be done using computer generated random number sequencing using block sizes of 2 & 4. Allocation concealment will be done using serially numbered opaque sealed envelopes.

 

Procedure: Tn-ECHO examination will be done by senior neonatologist trained in basic neonatal ECHO. Sonosite Fujifilm 2D-ECHO machine will be used. Before examination all the noxious stimuli will be minimized. Babies in both groups will receive non pharmacological pain relief intervention in form of containment and facilitated tucking. Alarms of all equipments will be minimized. All subjects will be evaluated 5 minutes before Tn-ECHO for PIPP-R score & physiological parameters like HR, RR, spO2, PI (heart rate, respiratory rate, blood pressure, transcutaneous oxygen saturation, perfusion index) will be recorded. For behavioral components of PIPP-R score video recording will be done using a smart phone. Babies in Group A WILL RECEIVE 1ML/KG OF EXPRESSED BREAST MILK WHICH WILL BE SWABBED OVER THE BUCCAL MUCOSA. Babies randomized to Group B will receive no additional intervention. PIPP-R score & other physiological parameters will be recorded during the examination and 5 minutes after completion of Tn-echo examination. Behavioral score component of PIPP-R will be interpreted from the video recording by two independent neonatologists who will be blinded to the intervention.

 

Table 1: Physiological parameters of newborn related to tn-ECHO examination

 

5 mins Before examination

During examination

5 mins after examination

HR (per min)

 

 

 

RR (per min)

 

 

 

Spo2 (%)

 

 

 

PI

 

 

 

SBP (mmHg)

 

×

 

DBP (mmHg)

 

×

 

MAP( mmHg)

 

×

 

HR: Heart Rate, RR: Respiratory Rate, Spo2: Transcutaneous oxygen saturation pre-ductal, PI: Perfusion Index, SBP: systolic Blood Pressure, DBP: Diastolic Blood Pressure, MAP: Mean Arterial Pressure.

PIPP-R scoring figure taken from 2013 Lippincott Williams & Wilkins.

 
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