| CTRI Number |
CTRI/2020/10/028714 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CPR Training for parents of at risk newborn |
|
Scientific Title of Study
|
Feasibility of cardiopulmonary resuscitation training for parents of high risk newborn |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ShashidharA |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Neonatology
St.Johns Medical College
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916069965 |
| Fax |
|
| Email |
shashiishere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ShashidharA |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Neonatology
St.Johns Medical College
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916069965 |
| Fax |
|
| Email |
shashiishere@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Mukundan |
| Designation |
Research Scientist |
| Affiliation |
St.Johns Medical college and hospital |
| Address |
St.Johns Research Institute
Sarjapur Road
Bangalore
Sarjapur Road
Bangalore
560034
Karnataka
Bangalore
KARNATAKA
560034
India |
| Phone |
8897827650 |
| Fax |
|
| Email |
lakshmi.mukundan@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College is providing infrastructure support for the study |
|
|
Primary Sponsor
|
| Name |
DrShashidhar |
| Address |
St.Johns Medical College
Sarjapur Road
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 Shashidhar |
St.Johns Medical College Hospital |
Department of Neonatology
First floor
Sarjapur Road
Bangalore
Bangalore
KARNATAKA |
9916069965
shashiishere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St. John’s Medical College, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary care givers of high risk newborn babies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cardiopulmonary resuscitation training |
The primary caregiver will be demonstrated resuscitation by Primary Investigator or a Nurse who is trained in Basic NRP course once the eligible neonate in NICU is stable and ready for discharge. They will be taught a modified version of basic NRP as shown below(fig1). The caregiver will be allowed to practice(hands on) using Baby Ann mannequin, Self inflating bag, Delee’s mucus extractor and a shoulder roll till she is confident and able to do all the steps appropriately. One day prior to discharge, she/he will be assessed and scored. A score of all 75% that icludes 4 mandatory steps(bold letters table 1) is considered to be passed. If she scores less than the required score, she will be re-trained and allowed to practice. On the day of discharge, she will be allowed to attempt re-test and scored again. |
| Comparator Agent |
Not Applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregiver of High risk newborns with gestational age <34wks, birth weight <1500g, neurologically abnormal at discharge |
|
| ExclusionCriteria |
| Details |
Parents not willing to consent for training |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effectiveness of training primary caregiver of the newborn to effectively deliver cardiopulmonary resuscitation |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the acceptability of resuscitation training in parents of high risk newborns
2.To assess the need of resuscitation after discharge and parental anxiety at the end of one month
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/11/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vulnerable
infants like premature, low birth weight, neurologically abnormal are more
prone for sudden infant death syndrome. The significant number of these events
occur at home post-discharge. If the parents are able identify warning signs
and able to provide resuscitation, most of these sudden events can be reduced.
Cardiopulmonary resuscitation teaching for parents before an infant’s hospital
discharge is the usual practice in many neonatal intensive care units. Our
hospital data(NNPD) from 2017 January to December showed 292 babies <2000g
were admitted in our NICU. Out of which 5 babies had post discharge postnatal
death. Hence, to prevent these events, this study is undertaken with the above
objectives. However the evidence for this is very limited in developing
countries like India.
|