| CTRI Number |
CTRI/2024/06/068407 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quality improvement |
| Study Design |
Other |
|
Public Title of Study
|
Quality improvement study to improve the discharge preparedness for preterm neonates in a tertiary care centre |
|
Scientific Title of Study
|
A Quality Improvement study to improve the discharge preparedness for preterm neonates in Neonatology unit of PGIMER, Chandigarh, 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinju Shaji |
| Designation |
Msc Nursing Student |
| Affiliation |
NINE, PGIMER ,Chandigarh |
| Address |
Department of child health nursing
National Institute of nursing education
PGIMER
Chandigarh
Kunnappallil House
Koovappally PO
Kottayam, 686518
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8921479574 |
| Fax |
|
| Email |
chinjushaji720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chinju Shaji |
| Designation |
MSc Nursing Student |
| Affiliation |
NINE, PGIMER ,Chandigarh |
| Address |
Department of child health nursing, NINE
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8921479574 |
| Fax |
|
| Email |
chinjushaji720@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinju Shaji |
| Designation |
MSc Nursing Student |
| Affiliation |
NINE, PGIMER ,Chandigarh |
| Address |
Department of child health nursing, NINE
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8921479574 |
| Fax |
|
| Email |
chinjushaji720@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
PGIMER, Sector 12 Chandigarh 1600129 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NINE PGIMER Chandigarh |
National Institute of Medical Education PGIMER Chandigarh, 1600124 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushma Saini |
PGIMER, Chandigarh |
PGIMER, Sector12 Chandigarh 160012
Chandigarh
CHANDIGARH |
8921479574
sushmadrsaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P073||Preterm [premature] newborn [other], (2) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Parents of preterm neonates and HCP who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Parents and HCP who are not willing to participate in the study2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of discharge preparedness for preterm neonates |
To improve the quality of discharge preparedness by 25% from base line within a period of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the knowledge & skill of nurses, doctors, other health care workers & caregivers
regarding the discharge preparedness for preterm neonates |
Knowledge & skill of nurses, doctors, other health care workers & caregivers
2regarding the discharge preparedness in 12 weeks & a follow up of preterm neonates after one 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)
|
01/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study entitled " Quality improvement study to improve discharge preparedness for preterm neonates in Neonatology unit of Nehru hospital, PGIMER, Chandigarh, mainly aimed to improve to develop and implement guidelines in discharge preparedness through QI team. |