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CTRI Number  CTRI/2018/05/014006 [Registered on: 21/05/2018] Trial Registered Prospectively
Last Modified On: 16/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing Kangaroo Mother Care and Sucrose in Reducing Pain in Preterm Neonates on Heel Prick. 
Scientific Title of Study   Randomized controlled double masked crossover trial comparing Kangaroo Mother Care and Sucrose in Reducing Pain in Preterm Neonates on Heel Prick 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Somashekhar Nimbalkar 
Designation  Head of Department 
Affiliation  Shree Krishna Hospital 
Address  Department of Pediatrics, Shree Krishna Hospital,Pramukhswami Medical College, Karamsad,Anand,Gujarat.

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax  02692223466  
Email  somu_somu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Somashekhar Nimbalkar 
Designation  Head of Department 
Affiliation  Shree Krishna Hospital 
Address  Department of Pediatrics, Shree Krishna Hospital,Pramukhswami Medical College, Karamsad,Anand,Gujarat.

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax  02692223466  
Email  somu_somu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Somashekhar Nimbalkar 
Designation  Head of Department 
Affiliation  Shree Krishna Hospital 
Address  Department of Pediatrics, Shree Krishna Hospital,Pramukhswami Medical College, Karamsad,Anand,Gujarat.

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax  02692223466  
Email  somu_somu@yahoo.com  
 
Source of Monetary or Material Support  
Charutar Arogya Mandal. Charutar Arogya Mandal runs the institution the PI works in. It is located at Gokalnagar, Karamsad, Gujarat, India. Details can be found at www.charutarhealth.org 
 
Primary Sponsor  
Name  Charutar Arogya Mandal 
Address  Shree Krishna Hospital,Pramukhswami Medical College, Karamsad,Anand,Gujarat 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof Somashekhar Nimbalkar  Department of pediatrics,Shree Krishna Hospital,Pramukhswami Medical College, Karamsad,Anand,Gujarat 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Somashekhar Nimbalkar  Pramukhswami Medical College  Neonatal Intensive Care Unit, Shree Krishna Hospital Gokalnagar, Karamsad, Anand, Gujarat
Anand
GUJARAT 
9825087842

somu_somu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients receiving Heel prick procedures in NICU,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kangaroo Mother care (KMC)  To one neonate KMC first group would be provided at least 15 min in advance and would continue the intervention at least 15 min post procedure. Kangaroo mother care would be provided by immediate care-givers, volunteers as per the existing protocols.  
Intervention  Sucrose  Sucrose reduces pain in neonates. We want to see how sucrose compares to KMC 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  28-36 weeks gestation neonates 
 
ExclusionCriteria 
Details  1.Neonates on ventilator

2. Clinically evident abnormal neurological signs

3. Have received analgesics/sedatives within last 24 h.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Premature infant pain profile(pipp)score at end of procedure.  Measured at various intervals during painful procedure.
0,30,60 at 30 second intervals till completion of procedure.
 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/06/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

.International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Sucrose has been shown to be effective. Breast feeding is effective, but has only been reported to be used for pain control in full-term neonates. Premature infants are not being breast fed during the days when most invasive procedures are carried out as they may not have the developmental maturity. It is proposed that it may be the contact of breast feeding, and not the breast milk per se, which is efficacious in decreasing pain . Thus for the preterm group, KMC would be a cost effective analgesic and provide mothers a greater sense of responsibility for their sick babies. Studies have compared the effect of KMC and oral sucrose on pain response in neonates and show that KMC acts synergistically with other nonpharmacological modalities in reducing pain . Multiple studies have shown the benefits of Kangaroo mother care and oral Sucrose on neonatal pain reduction.

Neonates born prematurely who spend the initial weeks of their lives in NICUs, undergo many invasive procedures (an average of 2–3/d, up to 8–10 /d) without benefit of analgesia of which heel pricking is one of the most common procedure.pain associated with routine procedures in preterm neonates is associated with abnormal neurodevelopment ,the effects of which may be persistent so it is of extreme importance to treat and reduce pain, especially premature neonates during their stay within the NICU. 
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