| CTRI Number |
CTRI/2025/07/090867 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Experiences of staff nurses regarding developmentally supportive care for preterm neonates admitted in Neonatal Intensive Care Unit |
|
Scientific Title of Study
|
Perception of staff nurses on developmentally supportive care for preterm neonates admitted in Neonatal Intensive Care Unit (NICU) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeffy George |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller College Of Nursing |
| Address |
Child Health Nursing Department
Floor NO. 3
Father Muller College of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9946286510 |
| Fax |
|
| Email |
jeffygeorge2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeffy George |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller College Of Nursing |
| Address |
Child Health Nursing Department
Floor NO: 3
Father Muller College of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9946286510 |
| Fax |
|
| Email |
jeffygeorge2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandra Jyothi Saldhanha |
| Designation |
Professor |
| Affiliation |
Father Muller College Of Nursing |
| Address |
Child Health Nursing Department
Floor NO. 3
Father Muller College of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9900412965 |
| Fax |
|
| Email |
sanjyothsal@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jeffy George |
| Address |
Post Graduate Student
Father Muller College Of Nursing
Kakanady
Mangalore
Karnataka
India,575002 |
| 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 |
| NR Manoj PS |
Father Muller Medical College Hospital |
Neonatal Intensive Care Unit
First Floor
Father Muller Medical Collage Hospital
Kankanady
Mangalore
Karnataka
India
575002
Dakshina Kannada
KARNATAKA |
7090633545
manojps.ps@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Instituitonal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Staff nurses who are act as a primary care provider for a preterm neonates
Staff nurses who are experienced |
|
| ExclusionCriteria |
| Details |
NIL
No exclusion criteria
Staff nurse who are working other than NICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Staff Nurses have adequate knowledge regarding Developmentally Supportive Care of Preterm Neonates |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better care given for preterm neonates through developmentally supportive care at Neonatal Intensive Care Unit |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study aims to give better care for preterm neonates through developmentally supportive care at Neonatal Intensive Care Unit and to improve staff nurses knowledge . |