| CTRI Number |
CTRI/2021/09/036220 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the power of breast milk VS glusose solution in reducing the pain during treatment. |
|
Scientific Title of Study
|
Efficacy of 10% dextrose VS expressed breast milk in relieving procedural pain in neonates- A randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuvasri Alias Shanthini |
| Designation |
Postgraduate |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL,
KALITHEERTHALKUPPAM,
MADAGADIPET
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8072330324 |
| Fax |
|
| Email |
shantu.smileplease@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Bharat Kumar |
| Designation |
Professor |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL,
KALITHEERTHALKUPPAM,
MADAGADIPET
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yuvasri Alias Shanthini |
| Designation |
Postgraduate |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL,
KALITHEERTHALKUPPAM,
MADAGADIPET
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8072330324 |
| Fax |
|
| Email |
shantu.smileplease@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF,
Sri manakula vinayagar medical college and hospital,
madagadipet,
puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
Yuvasri Alias Shanthini |
| Address |
Sri Manakula Vinayagar College and Hospital
kalitheerthalkuppam, Madagaipet, Pondicherry |
| 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 |
| Yuvasri Alias Shanthini |
Sri Manakula Vinayagar Medical College and Hospital |
Neonatal intensive care unit ,
Department of pediatrics,
Kalitheerthalkupam, madagadipet,puducherry
Pondicherry
PONDICHERRY |
8072330324
shantu.smileplease@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% Dextrose |
1ml of the 10% dextrose solution is administered orally with 3ml syringe to the patient before 30 seconds of the procedure and the pain response is assesed with Premature Infant Pain Profile score at 0 sec, 30 sec, 60 secs of procedure. |
| Comparator Agent |
Expressed breast milk |
1ml of the expressed breast milk is administered orally with 3ml syringe to the patient before 30 seconds of the procedure and the pain response is assesed with Premature Infant Pain Profile score at 0 sec, 30 sec, 60 secs of procedure. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates born between ≥34 to ≤42 weeks of Gestational age who have indication to
undergo heel prick for capillary blood glucose estimation.
2. Neonatal age since birth to less than or equal to 28days. |
|
| ExclusionCriteria |
| Details |
1. Babies with Sepsis
2. Babies with congenital malformations
3. Babies under sedation
4. Neonates who are already crying
5. Babies passing urine or stools during the procedure
6. Babies on Nil Per Oral
7. 5mins APGAR of <7
8. Parents refusal to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of 10% Dextrose and Expressed breast milk on relieving
procedural pain in neonates assessed by Premature Infant Pain Profile. Score less than 6 is mild and score more than 12 is moderate to severe pain. |
o , 30 , 60 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Through this research the procedural pain in neonates is being reduced by giving 10% dextrose
and Expressed Breast Milk might decrease the possible neurodevelopmental damage produced due
to pain. This would also help us in formulating protocols for reducing procedural pain in our NICU
in future.
|
4months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2021 |
| Date of Study Completion (India) |
30/12/2021 |
| 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
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomized controlled trial. A sample of 72 neonates between the gestational
age of ≥34 to ≤42 weeks will be taken and are randomized into 2 groups by computer generated
numbers. After obtaining informed written consent from the parents, neonates will be included in
the study. Gestational age is confirmed with modified Ballard scoring. Before 30 seconds of heel
prick, One group of neonate is administered 1ml of 10% dextrose by 2ml sterile syringe and other
group is administered 1ml of Expressed Breast Milk by 2ml sterile syringe of the respective mother
by the principal investigator. With the baby lied on the radiant warmer, It is given per oral drop by
drop on the anterior aspect of tongue with the baby in supine position. 30 sec after administration
of the dextrose or Expressed Breast Milk, heel prick is done in the lateral aspect of the heel with a gun needle and
response to procedural pain is being assessed by Premature Infant Pain Profile score at 0s, 30s, 60s after heel prick. Two
independent observers are chosen.
Observer 1: An intern will be videotaping the facial and behavioral changes in the neonate i.e.
after instillation of the solution to the baby to 60sec after heel prick. Observer 1: An intern will be videotaping the facial and behavioral changes in the neonate i.e.
after instillation of the solution to the baby to 60sec after heel prick.
Observer 2: A Post graduate resident shall record HR, SPO2 saturation of the neonate from the
multiparameter monitor. Baseline value and at 0s, 30s and 60s after heel prick are noted.
Outcome variables are measured by Premature Infant Pain Profile score.8 PIPP is the reliable
measure of pain with a minimum score of 0 and maximum score of 21.
It includes 7 indicators. 2 contextual (Gestational age, Behavioral state) 2 physiological (Change
in heart rate, Change in oxygen saturation) 3 behavioral (Brow bulge, Eye squeeze, nasolabial
furrow). Scores ranges from 0, +1, +2, +3 for each indicator. In general <6 is minimal pain. >12
is moderate to severe pain. Maximum PIPP score is 21 preterm babies, 18 for term babies. Calculate the total score by adding subtotal score (physiological + facial indicators) and behavioral
score and the efficacy is interpreted. An independent observer will be analyzing the video and will
score all the videos in the end to avoid interobserver variation. The observer who interprets the
video and records PIPP score, will be blinded on what intervention is given. Subgroup analyses
will be done at the end of the study.
Scoring instructions for PIPP scoring
1.Observe the baby for 15 sec at rest and asses the vital sign indicator. Highest Heart rate
(HR), lowest spo2 saturation and behavioral state.
2. Observe the infant for 0, 30sec ,60 sec following the painful event. Score physiologic
and facial changes seen during this time and record immediately
3. Score for corrected Gestational age (GA) and behavioral state (BS) assessment if the
subtotal is >0
5. Record full PIPP score. Calculate the score by adding Sub-total score and Behavioral score. |