| CTRI Number |
CTRI/2016/12/007540 [Registered on: 06/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Homeopathy
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two methods of surfactant administration, through Laryngeal mask airway and endotracheal tube in preterm babies with Respiratory distress syndrome |
|
Scientific Title of Study
|
Laryngeal mask airway Versus Endotracheal tube for Surfactant administration in Respiratory Distress Syndrome in Preterm neonates more than 30 weeks of gestation-A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramkumaar |
| Designation |
MD(Pediatrics)., DM Neonatology Resident., |
| Affiliation |
Affiliation |
| Address |
Institute of Child health and Hospital for Children,
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9790971177 |
| Fax |
|
| Email |
rampaediatricsmddm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangala Bharathi |
| Designation |
Professor of Neonatology |
| Affiliation |
Affiliation |
| Address |
Institute of Child health and Hospital for Children,
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9840786836 |
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramkumaar |
| Designation |
MD(Pediatrics)., DM Neonatology Resident., |
| Affiliation |
Affiliation |
| Address |
Institute of Child health and Hospital for Children,
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9790971177 |
| Fax |
|
| Email |
rampaediatricsmddm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ramkumaar |
| Address |
DM Resident
Department of Neonatology Institute of Child health and Hospital for Children,
Egmore
Chennai 600 008
|
| Type of Sponsor |
Other [Dr Ramkumaar] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramkumaar |
Number 99, 1ST floor, Department of Neonatology,Institute of child health and hospital for children |
Department of Neonatology,Institute of child health and hospital for children
Chennai
TAMIL NADU |
9790971177
rampaediatricsmddm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,madras medical college ,chennai-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group : Surfactant administration through Endotracheal tube
|
Surfactant would be administered through endotracheal tube ,as a standard of care for babies diagnosed to have Respiratory distress syndrome |
| Intervention |
Intervention group : Surfactant administration through Laryngeal mask airway
|
surfactant would be administered through the babies diagnosed ton have respiratory distress syndrome through laryngeal mask airway |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1.Birth weight of more than 1200 grams
2.Gestational age of more than 30 weeks
3.Chronological age of less than 48 hours
4.Diagnosis of RDS with clinical and radiological criteria
5.Requiring nasal CPAP with Peep of less than 7 and FiO2 between 0.4 to 0.7
6.Hemodynamically stable
A written consent will be obtained from the parents / care givers of the infant for willingness for enrolment in the study
|
|
| ExclusionCriteria |
| Details |
1.Babies who underwent Endotracheal intubation earlier
2.Analgesia & or sedation during first 6 hours of life
3.APGAR score of less than 3 at 5 minutes of life
4.Babies with Major congenital anomalies |
|
|
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 within 48 hours of intervention |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Any need for mechanical ventilation
2.Evaluation of pain (Neonatal Infant Pain score)
3.Duration of oxygen requirement
4.Rate of pneumothorax
5.Compilations related to the intervention
6.Incidence of Sepsis
7.Mortality |
Till the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2015 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open labelled, parallel group, single-centred trail comparing the safety and efficacy of surfactant administration through laryngeal mask airway and endotracheal tube in preterm neonates more than 30 weeks of gestation. This study was designed based on the hypothesis that Surfactant administration through Laryngeal mask airway will decrease the need for intubation in babies with Respiratory distress syndrome , when compared to standard surfactant administration through endotracheal tube in preterm neonates more than 30 weeks of gestation. Primary outcomes measured would be the need for mechanical ventilation within 48 hours of intervention. The secondary outcomes measured would be any need for mechanical ventilation, evaluation of pain scores (Neonatal Infant Pain score), duration of oxygen requirement, rate of pneumothorax, compilations related to the interventions, incidence of Sepsis and mortality rate. |