| CTRI Number |
CTRI/2023/08/056687 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Drug Utilization and safety in Sick Newborn Care Unit of a Tertiary Care Hospital in Uttarakhand |
|
Scientific Title of Study
|
Evaluation Of Trend and Rationale of Prescription, Drug Utilization Pattern and Safety in Sick Newborn Care Unit of a Tertiary Care Hospital in Uttarakhand: An Observational Cross-Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Libin Sanjeev L |
| Designation |
JR 1 |
| Affiliation |
Government Doon Medical College, Dehradun |
| Address |
Department of Pharmacology, Government Doon Medical College, Patel Nager, Dehradun, Uttarakhand
Flat: 3, Block: 58, Krishna Homes, THDC Colony, Dehrakhas, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9943308101 |
| Fax |
|
| Email |
libinmedico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Gaur |
| Designation |
Professor & HOD |
| Affiliation |
Government Doon Medical College, Dehradun |
| Address |
Department of Pharmacology, Government Doon Medical College, Patel Nager, Dehradun, Uttarakhand
Type 3, GDMC Campus, Patel Nager, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9943308101 |
| Fax |
|
| Email |
pharmacologygdmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Libin Sanjeev L |
| Designation |
JR 1 |
| Affiliation |
Government Doon Medical College, Dehradun |
| Address |
Department of Pharmacology, Government Doon Medical College, Patel Nager, Dehradun, Uttarakhand
Flat: 3, Block: 58, Krishna Homes, THDC Colony, Dehrakhas, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9943308101 |
| Fax |
|
| Email |
libinmedico@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Doon Medical College, Dehradun |
|
|
Primary Sponsor
|
| Name |
Government Doon Medical College |
| Address |
Department of Pharmacology, Government Doon Medical College, Patel Nager, Dehradun, Uttarakhand - 248001 |
| 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 |
| Libin Sanjeev L |
Government Doon Medical College |
Department of Pharmacology, Government Doon Medical College, Dehradun
Dehradun
UTTARANCHAL |
9943308101
libinmedico@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates admitted to SNCU and receiving at least 1 drug |
|
| ExclusionCriteria |
| Details |
Neonates admitted in the SNCU exclusively for oxygen therapy, vaccines, blood products, electrolytes, total parenteral nutrition and intravenous hydration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| drug utilization patterns in the Sick Newborn Care Unit using WHO drug use indicators |
The Drug utilization will be recorded at the time of discharge of each patient and The WHO indicators will be assessed at the end of one year for the entire data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate rationale of drugs prescribed in SNCU |
1 year |
| To evaluate potential drug interactions of drugs prescribed in SNCU |
1 year |
| To evaluate length of stay in SNCU of GDMC Hospital |
1 year |
| To monitor adverse drug reactions of drugs prescribed in SNCU |
1 year |
| To evaluate cost of drug therapy in SNCU based on cost per DDD |
1 year |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="270" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2023 |
| Date of Study Completion (India) |
30/09/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Neonatal Mortality Rate (NMR) In developing countries is 27 deaths per 1,000 births. In India
its 25 per 1,000 live births and in Uttarakhandit is 32.4 per 1000 live births {National Family Health
Survey -5 (NFHS-5) report}. Children with life threatening conditions need intensive care & treatment in
Sick Newborn Care Units (SNCUs) with more drug orders (polypharmacy). There is paucity of data
related to drug utilization patterns, adverse drug reactions, drug-drug interactions, cost and rationale
of prescribed medications and length of stay of neonates in SNCUs of Uttarakhand state.
A observational cross-sectional study will be conducted in the Department of Pharmacology in
collaboration with the Department of Paediatrics at Government Doon Medical College and Hospital for
a duration of 12 months.
|