| CTRI Number |
CTRI/2025/02/080744 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study of Drug Use Pattern in Neonatal Intensive Care Unit |
|
Scientific Title of Study
|
Pattern of Drug Use in Neonatal Intensive Care Unit: A Prospective Observational 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 |
Dr Tushar Chauhan |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
8279695395 |
| Fax |
|
| Email |
drchauhantushar1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navjot Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9478610996 |
| Fax |
|
| Email |
drnavjotpharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tushar Chauhan |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
8279695395 |
| Fax |
|
| Email |
drchauhantushar1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Pin code-147001, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology GMC Patiala |
| Address |
Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Pin code-147001, Punjab, India. |
| Type of Sponsor |
Government medical college |
|
|
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 Tushar Chauhan |
Government Medical College and Rajindra Hospital Patiala |
Neonatal Intensive Care Unit, MCH Building, Department of Pediatrics
Patiala
PUNJAB |
8279695395
drchauhantushar1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) Government Medical College Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates of either gender admitted to NICU for more than 24 hours and receiving atleast one drug. |
|
| ExclusionCriteria |
| Details |
1) Parents/guardians refuse to provide written informed consent.
2) Neonates with missing clinical data.
3) Neonates admitted only for observation.
4) Neonates receiving only vaccination, total parenteral nutrition, phototherapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study overall pattern of drug utilization in NICU using WHO core prescribing indicators. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To describe drug utilization pattern of vasoactive agents.
2. To describe drug utilization pattern of antibiotics.
3. To identify potential drug-drug interactions, |
1 year |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
01/03/2025 |
| 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
|
Drug utilization studies
focus on how medicines are prescribed in real world clinical practice. These
studies provide insights into rationality of drug use and can guide improvement
in prescribing practices. There is paucity of data regarding medicine use in
neonatal ICUs from India. The
aim is to study the pattern of drug utilization in NICU using WHO core
prescribing indicators. A prospective observational study will be conducted
over a period of 12 months in Neonatal Intensive Care Unit (NICU) of our
hospital. Study related data will be extracted from the medication charts after
obtaining written informed consent from the parent/guardian. Data will be
analyzed and presented using descriptive statistics.The study will generate data on current trends
of medicine use in neonates. This data can be used to analyze rationality of
drug use and identify future research priorities in neonates. |