| CTRI Number |
CTRI/2025/07/091567 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Retrospective study based on drug-drug interaction in neonates |
|
Scientific Title of Study
|
Assessment of potential drug-drug interactions in neonatal intensive care unit: a retrospective 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 |
Leona Valeria Pais |
| Designation |
PG student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760449917 |
| Fax |
|
| Email |
leonapais26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udeyv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udeyv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka 575018 |
| Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University),Paneer, Deralakatte, Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Other [Academic Institute] |
|
|
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 Uday Venkat Mateti |
Justices KS Hegde Charitable Hospital |
Department of Pediatrics, Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA |
8152977460
udeyv@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee(NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates(less than 28days) who have been admitted in NICU department at KS Hegde hospital, Neonates prescribed with at least 2 medications, All neonates both preterm and term will be included, Neonates with clear and complete patient data will be included. |
|
| ExclusionCriteria |
| Details |
Neonates born in any other hospital other than Justice KS Hedge Charitable hospital will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Common DDIs among neonates can be identified and categorized based on severity. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay can be correlated with the number of DDIs. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
03/08/2025 |
| 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="0"
Months="8"
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
|
Introduction: A neonate, or newborn infant under 28 days old, undergoes critical developmental changes and is highly vulnerable to health risks, including adverse drug events. Infants in the NICU are exposed to a large number of medications that increase the risk of causing potential drug-drug interactions and thereby lead to adverse drug events.
Objectives: • To assess the potential drug-drug interactions among neonates admitted to NICU department. • To assess the risk category of potential drug-drug interactions among neonates.
Methodology: A retrospective study will be conducted in NICU of Justice K.S. Hegde Hospital for 8 months, with a sample size of 240 neonates (2020–2024) using convenience sampling. Data will be collected on demographics, drugs prescribed, and potential DDIs analyzed and categorized using UpToDate and Medscape.
Inclusion criteria: • Neonates (<28 days of age) who have been admitted in NICU department at K.S. Hegde hospital. • Neonates prescribed with at least 2 medications. • All neonates, both preterm and term will be included • Neonate with clear and complete patient data will be included.
Exclusion criteria: • Neonates born in any hospital other than Justice K.S. Hegde charitable Hospital will be excluded.
Statistical analysis: The data will be entered in MS excel and analysed using SPSS [V29.0]. The continuous data will be expressed as mean +SD and categorical values will be presented in frequency [%]. Data will also be represented as graphs or diagrams
outcome: Common DDIs among neonates can be identified and categorized based on severity. Length of hospital stay can be corelated with the number of DDIs. |