| CTRI Number |
CTRI/2021/06/033944 [Registered on: 02/06/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two surfactant administration techniques to know which technique has better outcome result. |
|
Scientific Title of Study
|
Comparative study between intubate surfactant administration and extubate (INSURE) vs lesser invasive surfactant administration(LISA) technique for delivery of surfactant in newborn with respiratory distress syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushpendra Singh Mehra |
| Designation |
Primary DNB |
| Affiliation |
Swami Dayanand hospital |
| Address |
Swami Dayanand hospital
Pediatric department
Room no 315 third floor
OPD block
East
DELHI
110095
India |
| Phone |
9557799225 |
| Fax |
|
| Email |
dr.psmehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Saini |
| Designation |
Consultant and head of department |
| Affiliation |
Swami Dayanand hospital department of pediatrics |
| Address |
Room no 316 3 floor OPD block Department of Pediatric Swami Dayanand hospital Shahdra
East
DELHI
110095
India |
| Phone |
9810075126 |
| Fax |
|
| Email |
anilsaini.0410@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pushpender Singh Mehra |
| Designation |
Primary DNB |
| Affiliation |
Swami Dayanand hospital |
| Address |
Room no 315 OPD block third floor
Pediatric department
Swami Dayanand hospital
East
DELHI
110096
India |
| Phone |
09557799225 |
| Fax |
|
| Email |
dr.psmehra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Dayanand hospital Shahdra New Delhi 110095 |
|
|
Primary Sponsor
|
| Name |
Pushpender Singh Mehra |
| Address |
Room no 30 DNB hostel
Swami Dayanand hospital
Dilshad garden Shahdra 110095 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Swami Dayanand hospital |
Department of paediatrics swami Dayanand hospital Shahdra New Delhi 110095 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pushpender Singh mehra |
Neonatal intensive care unit(NICU) Swami Dayanand hospital |
Room no 54 second floor NICU
Pediatric department
East
DELHI |
9557799225
dr.psmehra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hospital institutional ethics committees (HIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J981||Pulmonary collapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insure technique |
Delivery of surfactant by INSURE technique in newborn with respiratory distress syndrome in newborn |
| Comparator Agent |
LISA |
Delivery of surfactant by LISA technique in respiratory distress syndrome in newborn and compare outcome with insure |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1)Preterm 28-36 weeks
2)Requirement of nasal continues airway pressure(ncpap) level beyond or equal to 5cm of water and fiO2 greater or equal to o. 30 to maintain sPO2 of 88-92%.
3)Requirement of nasal high flow nasal canula(NHHHFNC) level beyond or equal to 5L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%.
4)Requirement of free flow O2 to 2L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%. |
|
| ExclusionCriteria |
| Details |
1)Severe respiratory distress syndrome with high oxygen requirement and or severe respiratory acidocissuch that ventilatory support will be necessary after surfactant therapy, suggested FiO2 threshold at which intubation for surfactant will be considered is >60(lower threshold)
2)Pulmonary hypoplasia
3)Cyanotic heart disease
4)Antinatally diagnosed congenital lung anomalies
5)Requirement intubation for resuscitation at birth |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for mechanical ventilation in first 72 hours in preterm newborns with RDS administered surfactant by LISA and INSURE. |
Birth till first 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of mechanical ventilation needed between LISA and INSURE group
Duration of hospital stay between the LISA AND INSURE group
Need for supplement O2 between LISA and INSURE group. |
Birth till first 12 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/06/2021 |
| 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="11"
Days="19" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective study will be conducted in Department of Pediatrics, Swami Dayanand Hospital after obtaining the approval of Hospital Institutional Research Committee (HIRC) & Hospital Institutional Ethics Committee (HIEC). Preterm baby admitted to the NICU with a diagnosis ofrespiratory distress syndrome satisfying the inclusion criteria will be recruited after informed consent from the legal guardian. A detailed maternal and neonatal history and clinical examination of neonatal included in study will be carried out and recorded on a predesigned Performa. Block randomisation will be done by person who is not involved in the study using research randomizer from www.sealedenvelope.com. All the spontaneously breathing preterm neonates born in SDNH at <36weeks of gestation, who develop RDS, will be included in the study. Both groups will be placed on nCPAP or HHHNC or Low Flow oxygenwith FiO2 (>30%) adjusted to maintain O2 saturations of 90-95%. They will be given surfactant, if needed during first 12 hours of life. RDS will be diagnosed on the basis of prematurity, tachypnea with respiratory rate >60/minute, subcostal or intercostal chest recession, grunting, nasal flaring, and cyanosis. Respiratory support will be provided with an initial pressure of 5 to 7 cm of water and FiO2 of 0.3. They will be randomized into two groups for the technique of surfactant administration, LISA or INSURE. In LISA group, surfactant will be administered at a dose of 100 mg/Kg with the help of small catheter i.e LISA cathetor. Upper respiratory tract will be visualized with laryngoscope and the catheter will be passed 1-2 cm past the vocal cords. Surfactant will be delivered within 1-3 minutes in small aliquots, while the infant continue breathing with nCPAP, during and after the procedure.. The LISA catheter will beremoved immediately after the procedure. Infant’s heart rate and SpO2 will be monitored during the procedure via pulse oximetry. FiO2 will be adjusted to attain a target SpO2. In INSURE group, the infants will be intubated and surfactant will be administered successfully in 2-3 aliquots with endotracheal tube with same dose as in LISA group, while they will receive positive pressure ventilation via T-piece resuscitaire. After a brief period of positive pressure ventilation for 15-20 minutes, the endotracheal will be removed and the infants will be placed on nCPAP. The criteria for subsequent dose of surfactant and mechanical ventilation will be the same as in LISA group. All the data variables will be recorded for both groups on a specifically designed performa. |