| CTRI Number |
CTRI/2019/01/017180 [Registered on: 21/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The property Of Expressed Breast Milk In reducing pain during routine Screeing painful Procedure in Pre mature newborn-A Randomised Control Trial
|
|
Scientific Title of Study
|
Efficacy Of Expressed Breast Milk In reducing pain during routine Screening Procedure in Pre Term Neonates-A Randomised Control Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr samar pratim Nayak |
| Designation |
pediatric resident primary DNB |
| Affiliation |
MAZUMDAR SHAW MEDICAL CENTER NARAYANA HEALTH CITY BANGALORE |
| Address |
MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY
BOMMASANDRA
BANGALORE
Mazumdar Shaw medical center Narayana hrudayalaya
Bommsanndra
Bangalore
KARNATAKA
560099
India |
| Phone |
09938058020 |
| Fax |
|
| Email |
samardream@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harini Sreedaran |
| Designation |
Consultant pediatrics and Neonatologist |
| Affiliation |
MAZUMDAR SHAW MEDICAL CENTER NARAYANA HEALTH CITY BANGALORE |
| Address |
MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY
BOMMASANDRA
BANGALORE
Mazumdar Shaw medical center Narayana hrudayalaya
Bommsanndra
Bangalore
KARNATAKA
560099
India |
| Phone |
09880706620 |
| Fax |
|
| Email |
Harini.sreedaran.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr samar pratim Nayak |
| Designation |
pediatric resident primary DNB |
| Affiliation |
MAZUMDAR SHAW MEDICAL CENTER NARAYANA HEALTH CITY BANGALORE |
| Address |
MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY
BOMMASANDRA
BANGALORE
Mazumdar Shaw medical center Narayana hrudayalaya
Bommsanndra
Bangalore
KARNATAKA
560099
India |
| Phone |
09938058020 |
| Fax |
|
| Email |
samardream@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY BANGALORE |
|
|
Primary Sponsor
|
| Name |
Dr samar pratim nayak |
| Address |
MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY
BANGALORE |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SAMAR PRATIM NAYAK |
DEPARTMENT OF PEDIATRICS |
5TH FLOOR
MAZUMDAR SHAW MEDICAL CENTER
NARAYANA HEALTH CITY BANGALORE
Bangalore
KARNATAKA |
9938058020
samardream@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics committee |
Approved |
| Narayana health academic ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Expressed Breast Milk plus standard care |
5ml of EBM will be given to respective child before 5 mins of procedure according to code revealed from SNOSE along with standard care.After 5mins PIPP score will be assessed by one person during and after the procedure. |
| Comparator Agent |
Standard care(nesting, swaddling) |
At the end we will compare the analgesic efficacy of EBM in pre term neonates during routine painful screening procedures and compare it with child who received only standard care. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
6.00 Day(s) |
| Gender |
Both |
| Details |
All preterm/premature neonates inborn and admitted in NICU / IPD/ well baby,(<37wks,<2500gms) had APGAR scores ⩾7 at 5 minutes; were aged ⩾24 hours; were undergoing venepuncture |
|
| ExclusionCriteria |
| Details |
â–ªAll term neonates
â–ªDiagnosed with neurologic problems of any type, if they had received analgesic or sedative drugs within 24 hours of enrolment or neonates having cardio-respiratory compromise, sepsis, central nervous system depression and severe congenital malformations.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow). |
The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia) |
Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/01/2019 |
| Date of Study Completion (India) |
11/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Efficacy of expressed breast milk in reducing pain during routine screening procedure in pre term neonates-a randomised controlled trial |