| CTRI Number |
CTRI/2025/12/099879 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [RCT ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two ways of giving surfactant to preterm babies with breathing difficulty. |
|
Scientific Title of Study
|
Efficacy of Surfactant administration through Laryngeal Mask Airway (LMA) vs Less Invasive Surfactant Administration (LISA) in Preterm Neonates. |
| Trial Acronym |
LMA , LISA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil Bhalla |
| Designation |
Professor |
| Affiliation |
Pt. Bhagwat Dayal Sharma Institute of health sciences. |
| Address |
Department of Paediatrics,
Pt Bhagwat Dayal Sharma Institute of health sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9813743565 |
| Fax |
|
| Email |
kapil_bhalla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apurva Negi |
| Designation |
Junior Resident |
| Affiliation |
Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
| Address |
Department of Paediatrics,
Pt Bhagwat Dayal Sharma Institute of health sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8544731551 |
| Fax |
|
| Email |
apurvagomar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apurva Negi |
| Designation |
Junior Resident |
| Affiliation |
Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
| Address |
Department of Paediatrics,
Pt Bhagwat Dayal Sharma Institute of health sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8544731551 |
| Fax |
|
| Email |
apurvagomar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pt Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
| Address |
Pt Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
| 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 |
| Apurva Negi |
Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
Department of Neonatology,
Pt. Bhagwat Dayal Sharma Institute of Health Sciences, Rohtak, Haryana
Rohtak
HARYANA |
8544731551
apurvagomar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee ,Pt. B. D. Sharma PGIMS/UHS, Rohtak. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LISA Group |
Preterm neonates with respiratory distress syndrome requiring surfactant therapy will receive surfactant via the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopy while the neonate is breathing spontaneously on CPAP. Surfactant will be administered slowly through the catheter without mechanical ventilation. The catheter will be removed immediately after administration, and non-invasive respiratory support will be continued. |
| Intervention |
LMA Group |
Preterm neonates with respiratory distress syndrome requiring surfactant therapy will receive surfactant administration through a Laryngeal Mask Airway (LMA). The procedure will be performed at the bedside under continuous cardiorespiratory monitoring. After appropriate positioning, a suitably sized LMA will be inserted without endotracheal intubation. Surfactant will be instilled through the LMA in aliquots while the neonate is on continuous positive airway pressure (CPAP) or gentle positive pressure ventilation as required. The LMA will be removed after completion of surfactant administration, and the baby will be continued on non-invasive respiratory support.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants between 30 to 34+6 weeks of gestation who develop mild to moderate respiratory distress between 4 to 48 hours of birth, requiring FiO2 0.3 to 0.60 to maintain SpO2 88 to 95 percent on nCPAP of 5to 6 cm of H2O and signed the parental consent. |
|
| ExclusionCriteria |
| Details |
Previous intubation or Surfactant therapy.
Apgar score of greater than or equal to 3 at 5 min.
Pneumothorax prior to enrolment.
Severe RDS indicated by FiO2 greater than 0.60.
Newborns with major congenital anomalies (major malformations involving craniofacial, Cardiac or thoracic).
Newborns with perinatal asphyxia.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for mechanical ventilation within 72 hours of surfactant administration |
Within 3 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of hospital stay
Intraventricular haemorrhage (IVH)
Neonatal Necrotizing Enterocolitis
Mortality
|
Untill discharge or death. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2026 |
| 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 - NO
|
|
Brief Summary
|
Eligible preterm neonates will be randomized in two groups. Group 1 (LMA group) and Group 2 (LISA group) and allocation ratio will be kept in 1 is to 1 ratio. Before the procedure interface will be changed to snugly fitting nasal cannula for delivering Non- Invasive Positive Pressure Ventilation (NIPPV) and will be reinstituted prior NIPPV after completion of the procedure. Surfactant will be administered through LMA in group 1 and through LISA in group 2. Both groups will have the same pre-specified criteria for surfactant re-dosing. If FiO2 equal to 20 percent higher than the baseline FiO2 within 8 h of therapy, surfactant will be re-dosed in either group, after excluding other causes of respiratory insufficiency. Beyond 8 h of the First dose, re-dosing will be considered if FiO2 greater than or equal to 0.60 or if FiO2 greater than or equal to 0.30, associated with worsening clinical signs of RDS. Neonates will be then observed for parameters like need for Mechanical Ventilation, Transient Bradycardia or Desaturation, IVH, NEC, Duration of Hospital stay and Mortality and the data will be recorded. Neonates will be followed up till their discharge from the hospital or till the secondary outcome. All data will be analysed using suitable statistical methods and p-value less than 0.05 will be considered the cut off value for significance in all analysis involved. |