| CTRI Number |
CTRI/2021/04/032720 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Therapeutic ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Less invasive surfactant administration vs Intubation, surfactant and extubation in preterm neonates with respiratory distress syndrome |
|
Scientific Title of Study
|
To compare the need for mechanical ventilation between administration of surfactant by LISA and INSURE technique |
| Trial Acronym |
LISA Vs INSURE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeevita Raina |
| Designation |
Post graduate resident |
| Affiliation |
Department of Paediatrics, GMC Jammu |
| Address |
Department of Paediatrics, SMGS Hospital, GMC Jammu
GMC Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8492081614 |
| Fax |
|
| Email |
jeevitajanvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu Jamwal |
| Designation |
Professor |
| Affiliation |
Department of Paediatrics |
| Address |
Department of Paediatrics, SMGS Hospital, Gmc Jammi
GMC Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419148113 |
| Fax |
|
| Email |
ashu.sainik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashu Jamwal |
| Designation |
Professor |
| Affiliation |
Department of Paediatrics |
| Address |
Department of Paediatrics, SMGS Hospital, Gmc Jammi
GMC Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419148113 |
| Fax |
|
| Email |
ashu.sainik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, GMC Jammu |
|
|
Primary Sponsor
|
| Name |
Dr Ashu Jamwal |
| Address |
Department of Paediatrics, SMGS Hospital, GMC Jammu |
| Type of Sponsor |
Other [] |
|
|
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 Jeevita Raina |
Government medical College Jammu |
NICU, Department of Paediatrics, SMGS Hospital
Jammu
JAMMU & KASHMIR |
8492081614
jeevitajanvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMC Jammu Institutional Ethics committee |
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 |
| Comparator Agent |
INSURE method of surfactant administration |
Surfactant administration traditionally involved INSURE (Intubation, Surfactant administration and Extubation) technique first introduced by Victorin et al. in 1990 which requires intubation of trachea and positive pressure ventilation for a variable period of time.
1. Infants will be intubated with an appropriate sized endotracheal tube and surfactant (135mg/kg) administered as in LISA group while they received PPV using AMBU bag.
2. After extubation nCPAP started as in LISA group. Similar to LISA group no sedation or premedication will be used.
3. The criteria for subsequent doses of surfactant, and intubation, and mechanical ventilation will be the same as in the LISA group. |
| Intervention |
Less invasive surfactant administration method |
Less invasive surfactant administration (LISA) involves insertion of a thin catheter into the trachea of a spontaneously breathing infant and its removal immediately after surfactant administration without requiring intubation and mechanical ventilation even for a short period of time. Following LISA, surfactant spreads quickly, making use of its unique biophysical properties without the need for positive pressure ventilation.
1. A feeding tube of 6F based on individual preference will be prepared by marking a point indicating the desired depth of insertion beyond the vocal cords.
2. The required depth is calculated as nasotrageal length plus 1 cm. No sedation or vocal guard or forceps will be used.
3. The procedure being performed in the NICU by two trained persons.
4. Sedation and pain medication not administered before the procedure.
5. In NICU spontaneously breathing babies started on CPAP of 5cm of H2OandFiO2 and adjusted to achieve a target saturation of 90% to 95% using a bubble CPAP or ventilator CPAP based on availability
6. Heart rate and SpO2 will be monitored throughout the procedure.
7. Direct laryngoscopy will be performed . 6F feeding tube inserted through the vocal cords to desired depth with the CPAP prongs in situ directly with the hand without the help of any forceps. After catheter placement, the laryngoscope is removed.
8. The surfactant used will be Neosurf (bovine lipid extract surfactant suspension) Cipla pharmaceuticals, at a dose of 5mL/kg, ie, 135mg phospholipids per kg.
9. The surfactant being drawn up in a 5 to 10mL syringe and an additional 1mL of air drawn up into the syringe taking account for the dead volume of the catheter used. The surfactant will be given as a single bolus over 60 to 90seconds and the tracheal catheter immediately withdrawn.
10. Infants who suffer bradycardia (≤100 per min), desaturation (≤80%), or apnea lasting longer than 20seconds got PPV.
11. If the patient do not respond to the treatment and continued to require FiO2 more than 30% even after 6hours of giving surfactant, the patient will be given a second dose of surfactant by the same technique as was used during the first instillation of surfactant.
|
|
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Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1. Gestational age ≤ 34 weeks
2. Diagnosis of RDS based on clinical signs and confirmation by chest x ray findings and need for NIV support ( FiO2 >30 %; PEEP >6 H2O) to maintain saturation between 90% and 95% in the first 6 hours of life |
|
| ExclusionCriteria |
| Details |
1. Severe RDS been treated with endotracheal intubation
2. Major congenital malformation or complex CHD
3. Pulmonary haemorrhage
4. Cardiopulmonary failure
5. Congenital genetic metabolic disease
6. Gestational age less than 28 weeks
7. Transferred out of NICU with surgical treatment or other intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Need for mechanical ventilation in first 72 hours
|
First 72 hours after surfactant administration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of repeat dose of surfactant
|
6 hours after surfactant administration |
| Pneumothorax |
During hospitalisation |
| Early onset sepsis |
72 hours |
| Duration of oxygen requirement |
During hospitalisation |
| Duration of hospital stay |
During hospitalisation |
Apnea, bradycardia, or desaturation
|
During surfactant administration |
| Mortality |
During hospitalisation |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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 1 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a open labelled, two parallel arm, randomized controlled trail comparing less invasive surfactant administration (LISA) with conventional INSURE method of surfactant administration in preterm neonates with respiratory distress syndrome. Primary outcome will be the need for mechanical ventilation within 72 hours of life. Secondary outcomes will be Requirement of repeat dose of surfactant, pneumothorax, early onset sepsis, duration of oxygen requirement, duration of hospital stay, apnea, bradycardia, or desaturation during surfactant administration, mortality. LISA will be compared as a method to INSURE method for surfactant administration.
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