| CTRI Number |
CTRI/2025/06/088512 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of better fraction of inspired oxygen at thirty percent or 40 percent for administering surfactant in preterm babies with respiratory distress syndrome |
|
Scientific Title of Study
|
Early surfactant administration at two different fractions of inspired oxygen thresholds: 40 percentage vs 30 percentage; in preterm neonates 26 to 34 weeks of gestation with respiratory distress syndrome on nCPAP: An open labelled randomized controlled trial |
| Trial Acronym |
OpFiTS trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thaslima Kalathingal |
| Designation |
DM Resident |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Neonatology
AIIMS Raipur
Gate No5 ABlock First Floor
GE Road Tatibandh
Raipur 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8454091967 |
| Fax |
|
| Email |
thaslima.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Phalguni Padhi |
| Designation |
Associate Professor and Head |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Neonatology
AIIMS Raipur
Gate No5 ABlock First Floor
GE Road Tatibandh
Raipur 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9040632169 |
| Fax |
|
| Email |
phalguni2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Phalguni Padhi |
| Designation |
Associate Professor and Head |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Neonatology
AIIMS Raipur
Gate No5 ABlock First Floor
GE Road Tatibandh
Raipur 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9040632169 |
| Fax |
|
| Email |
phalguni2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Department of Neonatology
AIIMS Raipur
Gate No5 ABlock First Floor
GE Road Tatibandh
Raipur 492099 |
| Type of Sponsor |
Other [Nonsponsored study] |
|
|
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 THASLIMA KALATHINGAL |
AIIMS |
Department of Neonatology
First Floor, ABlock.
Raipur
CHHATTISGARH |
08454091967
thaslima.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE All India Institute of Medical Sciences Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Neonates will receive surfactant if the FiO2 requirement within 2hrs is more than equal to 40 % to maintain preductal spO2 levels 91% to 95%. If FiO2 requirement is less than 40% then the babies will continue to receive respiratory support till the time the FiO2 requirement reaches 40% or more preferably within 6hrs of life, during which time surfactant will be instilled. If the FiO2 requirement doesnot reach 40%, then surfactant will not be administered and the neonate will be nursed on respiratory support only with strict monitoring of vitals and respiratory parameters to decide the need for either escalation or de-escalation of respiratory support |
| Comparator Agent |
GroupB |
neonates will receive surfactant if the FiO2 requirement within 2hrs is more than 30 % to maintain preductal spO2 levels 91% to 95%. If FiO2 requirement is less than 30% then the babies will continue to receive respiratory support till the time the FiO2 requirement reaches 30% or more preferably within 6hrs of life, during which time surfactant will be instilled. If the FiO2 requirement doesnot reach 30%, then surfactant will not be administered and the neonate will be nursed on respiratory support only with strict monitoring of vitals and respiratory parameters to decide the need for either escalation or de-escalation of respiratory support |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All preterm neonates 26 0/7 to 33 6/7 weeks of gestation with respiratory distress syndrome requiring FiO2 of more than equal to 30% or of more than equal to 40% on nCPAP/NIV as the initial mode of respiratory support within 2hours of birth admitted to the NICU. |
|
| ExclusionCriteria |
| Details |
1 Neonates requiring intubation in the delivery room or within two hours after birth
2 Life threatening congenital malformations
3 Other causes of respiratory distress other than RDS
4 APGAR less than 5 at 5min or cord gas pH less than 7 or base deficit of morethan equal to 16 |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion(%) of infants requiring intubation & mechanical ventilation in the first 72hrs of life |
First 72hrs of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Proportion of infants with death and BPD at 36 weeks of PMA |
at 36 weeks PMA
|
| 2. Duration of invasive ventilation support & oxygen support |
During NICU stay |
| 3. Duration of CPAP support |
During NICU stay |
| 4. Post surfactant CPAP settings PEEP and FiO2 |
12hrs after surfactant instillation |
| 5. Median time to receive surfactant |
72hrs of life |
| 6. Total number of surfactant doses received |
72hrs of life |
| 7. Oxygenation index, ratio of spO2 and FiO2, AaDo2 at day 3 of life |
Day 3 of life |
| 8. Morbidities- late onset sepsis, hs-PDA, severe IVH (grade ≥2), PVL (grade ≥2), severe ROP (stage2), severe NEC (≥stage 2a) |
During NICU stay |
| 9. Proportion of infants with air leaks, pneumothorax, pulmonary interstitial emphysema |
During NICU stay |
| 10. Length of hospitalization in days |
During NICU stay |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Respiratory Distress Syndrome is a common cause of
respiratory distress in preterm neonates. Surfactant is main stay in the
treatment of RDS. Depending on the severity of RDS, surfactant is instilled
based on FiO2 requirement. European consensus guidelines states FiO2
requirement of 30% to administer surfactant. But there exist different
recommendations regarding FiO2 threshold for receiving surfactant. This
study is planned to address the uncertainty in determining the optimal FiO2
threshold for surfactant administration in preterm neonates with RDS. The aim
of this study is to compare the effectiveness of two FiO2
thresholds ≥40%
vs ≥30% for
administering early surfactant in 26-34 weeks preterm neonates with
respiratory distress syndrome on nCPAP in reducing the need for mechanical
ventilation within 72hrs of life
|