| CTRI Number |
CTRI/2019/09/021050 [Registered on: 03/09/2019] Trial Registered Prospectively |
| Last Modified On: |
30/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hydrocolloid dressing] |
| Study Design |
Other |
|
Public Title of Study
|
A study on reducing nasal injury on preterm babies by Hydrocolloid Dressing Methods |
|
Scientific Title of Study
|
Effect of hydrocolloid dressing on nasal injury among preterm neonates on nasal continuous positive airway pressure(nCPAP): A randomized 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 |
Takhelmayum Bideshwori |
| Designation |
M.Sc. Nursing 2nd year (Pediatric nursing) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research,PONDICHERRY |
| Address |
Nightingale house, Room no-307; 3rd Floor, Paediatric Nursing Department , Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY;605006,India
Khurai Kongpal Chingangbam Leikai,Tinsid Road,Imphal East,Manipur
P.o. Porompat-795005
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8910505521 |
| Fax |
0413-2272066 |
| Email |
dansytakhelmayum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Vetriselvi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research,PONDICHERRY |
| Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY;605006,India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894459434 |
| Fax |
0413-2272066 |
| Email |
vetriselvijipmer1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Takhelmayum Bideshwori |
| Designation |
M.Sc Nursing 2nd year (Paediatric Nursing department) |
| Affiliation |
College of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry |
| Address |
Nightingale House,Room no.-307,3rd Floor ;Paediatric Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8910505521 |
| Fax |
0413-2272066 |
| Email |
dansytakhelmayum@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Takhelmayum Bideshwori |
| Address |
Nightingale House,Room no.-307, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. |
| 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 |
| Takhelmayum Bideshwori |
JIPMER |
Women and Child Health Hospital, NICU 1st Floor, Neonatology Department.
Pondicherry
PONDICHERRY |
8910505521
0413-2272066
dansytakhelmayum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee(Human studies),JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (2) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrocolloid dressing |
In group 1, hydrocolloid dressing will be applied on the preterm infants nostril before inserting nCPAP. |
| Comparator Agent |
Petrolatum jelly |
In Group2, petrolatum jelly will be applied on the preterm infants nostril before inserting nCPAP. |
|
|
Inclusion Criteria
|
| Age From |
5.95 Month(s) |
| Age To |
8.57 Month(s) |
| Gender |
Both |
| Details |
gestational age 25 to 36 weeks of gestation |
|
| ExclusionCriteria |
| Details |
Major congenital anomalies and nasal deformities. |
|
|
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 |
| To assess the effect of hydrocolloid dressing on nasal injury among preterm neonates on nCPAP. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the association of nasal injury with clinical characteristics of preterm neonates. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
27/09/2019 |
| 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="1"
Days="15" |
|
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
|
This study is a randomized controlled trial which will assess the effectiveness of hydrocolloid dressing on nasal injury among preterm neonates on nasal continuous positive airway pressure( nCPAP). The total sample is 78. Babies with gestational age 25-36 weeks are included in the study. Major congenital anomalies and nasal deformity or abnormal facial features will be excluded from the study. The study will be done in NICU, 1st Floor, JIPMER, Puducherry. |