| CTRI Number |
CTRI/2023/06/053850 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Docosahexaenoic acid supplementation in preterm neonates admitted in NICUand its effect on inflammatory markers at Day 10
|
|
Scientific Title of Study
|
Docosahexaenoic acid supplementation in preterm neonates admitted in NICU and its effect on inflammatory markers at Day 10- An open labelled Randomised controlled trail
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MARAMREDDY SAITEJA |
| Designation |
Pediatric junior resident |
| Affiliation |
Neonatal intensive care unit, RL jalappa hospital |
| Address |
Department of paediatrics,RL jalappa hospital,
Tamaka, Kolar-563103
Kolar
KARNATAKA
563103
India |
| Phone |
9494611244 |
| Fax |
|
| Email |
maramreddysaiteja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KNV Prasad |
| Designation |
Professor, Department of paediatrics |
| Affiliation |
RL Jalappa hospital, Tamaka, kolar |
| Address |
Department of paediatrics,Sri Devaraj Urs Academy of higher education and research
Tamaka, Kolar-563103
Kolar
KARNATAKA
563103
India |
| Phone |
9740551490 |
| Fax |
|
| Email |
drknvp@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MARAMREDDY SAITEJA |
| Designation |
Pediatric junior resident |
| Affiliation |
R L Jalappa Hospital, Tamaka , Kolar |
| Address |
Department of paediatrics,R L Jalappa Hospital,
Tamaka, Kolar-563103
Kolar
KARNATAKA
563103
India |
| Phone |
9494611244 |
| Fax |
|
| Email |
maramreddysaiteja@gmail.com |
|
|
Source of Monetary or Material Support
|
| NEONATAL INTENSIVE CARE UNIT, DEPARTMENT OF PAEDIATRICS, R L JALAPPA HOSPITAL,TAMAKA, KOLAR-563103 |
|
|
Primary Sponsor
|
| Name |
Saiteja |
| Address |
Department of pediatrics,Sri Devaraj Urs Academy of higher education and research
Tamaka, Kolar-563103, |
| 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 |
| MARAMREDDY SAITEJA |
RL JALAPPA HOSPITAL |
NEONATAL INTENSIVE CARE UNIT, DEPARTMENT OF PAEDIATRICS,R L JALAPPA HOSPITAL ,TAMAKA, KOLAR-563103,
Kolar
KARNATAKA |
9494611244
maramreddysaiteja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri devaraj Urs Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
Control group will receive only the standard neonatal feeding.
|
| Intervention |
DHA GROUP |
DHA group will receive (100mg/1ml)DOCOSAHEXANOIC ACID DROPS administered by enteral route with standard neonatal feeding.
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
-Early preterm neonates (32-34 weeks) delivered at RL Jalappa Hospital whose parents had consented to be a part in the study.
- Clincally stable neonates to begin enteral feeding |
|
| ExclusionCriteria |
| Details |
Neonates with congenital anomalies
-Neonates born to Mothers with PPROM history
-Neonates with contraindication for enteral feeding
-Neonates with maternal use of omega-3 supplements
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the inflammatory markers at day 10 of admission in babies with DHA supplementation
To measure the inflammatory markers at day 10 of admission in babies without supplementation of DHA
To compare the level of inflammatory markers between two groups
|
Day 10 of life
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the defined clinical outcomes i.e (sepsis, necrotising enterocolitis, bronchopulmonary dysplasia,and retinopathy of prematurity ) |
Hospital admission to discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preterm neonates are deficient in long chain polyunsaturated fatty acids (LCPUFA) especially DHA. DHA transfer in uterus occurs primarily in the last trimester of pregnancy reaching peak transfer rates at 35-40 weeks of gestation to support rapid growth and brain development. When the infant is exposed to a massive environmental antigenic assualt from the birth process and neonatal intensive care unit (NICU) can result in excess inflammation and a lowered ability to down-regulate immune responses once initiated. This heightened inflammation can trigger variety of inflammatory disorders such as sepsis, Necrotizing enterocolitis, Bronchopulmonary displasia, Retinopathy of prematurity. Therefore, there is a need to study supplementation of DHA in preterm neonates and to look whether there is any effect on inflammatory markers. So in my study i am supplementing DHA to study group and measuring whether supplementation of DHA has effect on inflammatory markers as a primary outcome and as a secondary outcome measuring defined clinical outcomes like ( Sepsis, Retinopathy of prematurity, Necrotizing enterocolitis, bronchopulmonarydysplasia) |