| CTRI Number |
CTRI/2024/10/075976 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Outcomes in preterm babies with respiratory distress syndrome when surfactant admnistration at different thershold(fio2-40 percent vs 30 percent) |
|
Scientific Title of Study
|
High (greater than 0.40) versus Low (greater than 0.30) Fractional Inspired Oxygen Threshold for Surfactant Therapy in Preterm Infants with Respiratory Distress Syndrome- A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADINENI VENKAT NAVEEN |
| Designation |
DM NEONATOLOGY |
| Affiliation |
IMS AND SUM HOSPITAL(SOA University) |
| Address |
IMS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),Ground floor..
.
Khordha
ORISSA
751003
India |
| Phone |
09505530553 |
| Fax |
|
| Email |
drmvnc2079@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEBASHISH NANDA |
| Designation |
DM NEONATOLOGY ,HOD |
| Affiliation |
IMS AND SUM HOSPITAL,SOA University |
| Address |
IMS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),Ground florr.
Khordha
ORISSA
751003
India |
| Phone |
9861422685 |
| Fax |
|
| Email |
debasishnanda@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MADINENI VENKAT NAVEEN |
| Designation |
DM NEONATOLOGY |
| Affiliation |
IMS AND SUM HOSPITAL,SOA University |
| Address |
IMS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),GROUNF FLOOR
Khordha
ORISSA
751003
India |
| Phone |
09505530553 |
| Fax |
|
| Email |
drmvnc2079@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),Ground floor,pincode-751003,India |
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
IMS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),Ground floo |
| Type of Sponsor |
Private 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 M VENKAT NAVEEN |
IMS AND SUM HOSPITAL(SOA University) |
MS AND SUM HOSPITAL(SOA University),k-8,Kalinga Nagar,Ghatikia,Bhubaneswar,Odisha,Department of Neonatology(NICU),Ground floor.
Khordha
ORISSA |
09505530553
drmvnc2079@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE,IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
babies given surfactant at fio2 30% |
if babies were randomization to fio2 30% ,we give surfactnt to babies,Total duration for 18 months |
| Intervention |
surfactant given at fio 40% |
all babies which were coming in my inculsion criteria were randomized ,if it comes in fio 40% surfactant will be given for total duration of 18 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1) Preterm Infants with gestation less than 36 weeks requiring CPAP respiratory support within 6 hours after birth.
2) Parental consent
|
|
| ExclusionCriteria |
| Details |
1) Preterm infants requiring directly mechanical ventilation in initial hours after birth.
2) Preterm infants with gestation less than 25 weeks.
3) Infants with major congenital anomalies including nasopharyngeal pathology including cleft palate.
4) Infants who are hemodynamically unstable requiring inotropes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the need for mechanical ventilation in the first 72 hrs following surfactant adminstration between 2 groups. |
From surfactant adminstration to next 72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of invasive /non-invasive/oxygen as respiratory support.
To compare the incidence of pneumothorax.
To compare the incidence of Bronchopulmonary dysplasia
|
From admission to till 12 weeks of life or till discharge, which is earlier |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
10/11/2024 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmvnc2079@gmail.com].
- For how long will this data be available start date provided 10-10-2026 and end date provided 10-10-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
preterm were major contributing for nicu admission ,in which major morbidity being respiartory disress syndrome,cornerstone mangement for respiratory distress syndrome is respiartory support(cpap/mechanical ventilator) and surfactant repalcement.we came long way from routine intubation and prophylatic surfactant admisnatration coupled with ongoing invasive mechanical ventilation,to the present day predominant approach of management mainly use of non inavsive support(cpap) and selctive surfactant admsinatration.most common parameter used is FIO2 thershold ,regrading thershold differnent bodies uses differnet fio2 thershold,we use fio2 thershold 30% (eurpoean guidelines 2022).but at this thershold there is possiblity of overuse of surfactant ,so this study was planned to bring optimal fio2 thershold for surfactant administration for babies stabilized on cpap.Aim of the study is to comapre the need for mechanical vetlation admistrating surfactant at high(0.40) versues low(0.30) fio2 thershold in preterm infants with respiratory distress syndrome ,with primary objective to compare the need for mechanical ventilation in the first 72hrs. |