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
|
|
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. |