| CTRI Number |
CTRI/2025/10/095663 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
This study will compare stress levels as per measured by salivary cortisol levels and standardised stress measurement scale in NICU admitted babies |
|
Scientific Title of Study
|
To corelate neonatal infant stressor scale (NISS) score with salivary cortisol levels in assessment of stress in preterm neonates admitted in NICU - A prospective cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek A |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru nagar , Belagavi |
| Address |
Post graduate student, department of Paediatrics,Jawaharlal Nehru Medical college, Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9113020476 |
| Fax |
|
| Email |
abhishek.ashok56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjana S Mahantashetti |
| Designation |
Professor and Principal |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru nagar , Belagavi |
| Address |
Professor and principal, department of Paediatrics,Jawaharlal Nehru Medical college, Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448157237 |
| Fax |
|
| Email |
niranjanasn@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek A |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru nagar , Belagavi |
| Address |
Post graduate student, department of Paediatrics,Jawaharlal Nehru Medical college, Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9113020476 |
| Fax |
|
| Email |
abhishek.ashok56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neonatal intensive Care Unit of Dr Prabhakar Kore Hospital and medical research centre, Nehru nagar , Belagavi, Karnataka, India , 590010 |
|
|
Primary Sponsor
|
| Name |
Abhishek A |
| Address |
Department of Paediatrics Jawaharlal Nehru medical college Nehru nagar Belagavi, Karnataka, India 590010 |
| 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 Abhishek A |
Neonatal Intensive care unit |
3rd floor, Neonatal intensive care unit of Dr Prabakar Kore Hospital
Belgaum
KARNATAKA |
9113020476
abhishek.ashok56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1.NICU admitted preterm neonates from 28 weeks to 37 weeks. |
|
| ExclusionCriteria |
| Details |
1.Infants who had known congenital anamolies on examination at birth
2.History of drug exposure during current pregnancy.
3.Mothers having chronic psychological illness including epilepsy.
4.Parents unwilling to participate in study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of associated risk factors with increased stress levels in infants |
Measurement of salivary cortisol at first 3 days of admission to NICU and after 3 days in admission to NICU |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
15/10/2025 |
| 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)
|
Not Applicable |
| 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
|
This prospective cohort study investigates the correlation between Neonatal Infant Stressor Scale (NISS) scores and salivary cortisol levels in preterm neonates (28–37 weeks) admitted to NICU. Ninety-six infants will be assessed for stress due to handling, environmental factors, and maternal risks. Findings may guide stress reduction strategies, improving neonatal outcomes. |