| CTRI Number |
CTRI/2020/07/026860 [Registered on: 28/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of combination of sucrose and other non pharmacological methods in reducing pain in newborns |
|
Scientific Title of Study
|
The effectiveness of the combination of sucrose and other non pharmacological methods over other non pharmacological methods alone in procedural pain management 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 |
Vinothini A |
| Designation |
DNB resident |
| Affiliation |
Pragna hospital |
| Address |
Department of pediatrics,
6-3-347/22/B/1, Dwarakapuri colony, Punjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
8297939018 |
| Fax |
|
| Email |
drvinothini2892@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar Surapaneni |
| Designation |
Consultant Neonatologist |
| Affiliation |
Pragna hospital |
| Address |
Pragna hospital,
Department of pediatrics,
6-3-347/22/B/1, Dwarakapuri colony,Punjagutta , Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
9848023967 |
| Fax |
|
| Email |
sskdr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh kumar Surapaneni |
| Designation |
consultant Neonatologist |
| Affiliation |
Pragna hospital |
| Address |
Pragna hospital,
Department of pediatrics,
6-3-347/22/B/1, Dwarakapuri colony, Punjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
9848023967 |
| Fax |
|
| Email |
sskdr1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pragna hospital, 6-3-347/22/B/1, Dwarakapuri colony, Punjagutta,
Hyderabad - 500082
Telengana |
|
|
Primary Sponsor
|
| Name |
Pragna hospital |
| Address |
6-3-347/22/B/1, Dwarakapuri colony, Punjagutta, Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Vinothini A |
Pragna hospital |
Pragna hospital, Department of Pediatrics,6-3-347/22/B/1, Dwarakapuri colony, Punjagutta, Hyderabad-500082.
Hyderabad
TELANGANA |
8297939018
drvinothini2892@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pragna hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1ml oral 24% sucrose solution, non nutritive sucking and facilitative tucking |
1ml oral 24% sucrose solution will be given once 2 minutes before heel prick, which will be followed by non nutritive sucking. Facilitative tucking will be done 30 seconds before heel prick |
| Comparator Agent |
1ml oral Sterile water (placebo), non nutritive sucking and facilitative tucking |
1ml oral Sterile water (placebo) will be given once 2 minutes before heel prick, which will be followed by non nutritive sucking. Facilitative tucking will be done 30 seconds before heel prick |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates who require heel prick for blood glucose measurement, preterm neonates > 32 weeks and term neonates |
|
| ExclusionCriteria |
| Details |
Infants older than 28 days, neonates with congenital anomalies,APGAR score < 7 at 5 minutes, sedated neonates, neonates who had undergone surgery and in post op period, Neonates at high risk for Necrotizing enterocolitis - asphyxiated neonates and neonates with feeding intolerance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PIPP (Premature infant pain profile) |
30 seconds
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of cry and
immediate adverse events |
till 3 minutes after heel prick |
|
|
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)
|
13/08/2020 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Infants hospitalized in NICU undergo frequent painful tissue-breaking procedures for diagnostic and therapeutic purposes .There are some studies established the use of sucrose 24% and other non pharmacological methods in pain management in NICU. My study is done to know whether there is significance difference between the combination of sucrose, non nutritive sucking and facilitative tucking over sterile water , non nutritive sucking and facilitative tucking in reducing heel prick pain in newborns. In this study neonates who will undergo heel prick are randomized into two groups. One group receives 24% sucrose solution, non nutritive sucking , facilitated tucking and other group receives sterile water (placebo) , non nutritive tucking , facilitated tucking. Pain score PIPP ( Premature infant pain profile ) will be assessed at 30 seconds and 2 minutes following heel prick . Duration of cry and adverse events will also be assessed following heel prick. |