| CTRI Number |
CTRI/2012/08/002868 [Registered on: 07/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
17/10/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasal interfaces for CPAP- what is best for the preterm infant? |
|
Scientific Title of Study
|
Nasal mask versus Nasal prongs in the delivery of Continuous positive airway pressure in preterm infants – an open label randomised controlled trial |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIESC/T-116/02.03.2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Chandrasekaran |
| Designation |
Senior resident, AIIMS, New Delhi |
| Affiliation |
All India Institute of Medical sciences, New Delhi |
| Address |
Senior resident,
Department of Pediatrics, All India Institute of medical sciences, New Delhi
Senior resident,
Department of Pediatrics, All India Institute of medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013860039 |
| Fax |
|
| Email |
appubanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Deorari |
| Designation |
Professor, Pediatrics, AIIMS, New Delhi |
| Affiliation |
All India Institute of Medical sciences, New Delhi |
| Address |
Prefessor,
Department of Pediatrics, All India Institute of medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818131391 |
| Fax |
|
| Email |
ashokdeorari_56@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Chandrasekaran |
| Designation |
Senior resident, AIIMS, New Delhi |
| Affiliation |
All India Institute of Medical sciences, New Delhi |
| Address |
Senior resident,
Department of Pediatrics, All India Institute of medical sciences, New Delhi
Senior resident,
Department of Pediatrics, All India Institute of medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013860039 |
| Fax |
|
| Email |
appubanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of medical sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences |
| Address |
All India Institute of medical sciences, Ansari Nagar,New Delhi -110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aparna Chandrasekaran |
Neonatal Intensive care unit- A (Dept of pediatrics), C3 ward, AIIMS |
All India Institute of medical sciences, Ansari Nagar, New Delhi-110029.
New Delhi
DELHI |
9013860039
appubanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics - committee, AIIMS, New Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm infants between 26-32 weeks gestation requiring continuous positive airway pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasal mask |
Application of continuous positive airway pressure (CPAP) through nasal CPAP masks available in 3 sizes. This is to be given continuously till the baby has respiratory distress. The baby shall be followed till 72 hours/ till whenever CPAP is stopped whichever is earlier. |
| Comparator Agent |
Nasal prongs |
Application of nasal continuous positive airway pressure by short bi-nasal prongs.This is to be given continuously till the baby has respiratory distress. The baby shall be followed till 72 hours/ till whenever CPAP is stopped whichever is earlier. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Preterm babies of 26+0 – 32+6 weeks of gestation
Respiratory distress requiring CPAP within 6 hours of life
Informed parental consent |
|
| ExclusionCriteria |
| Details |
Major congenital malformations
Any known anomaly known to interfere with delivery of CPAP such as congenital diaphragmatic hernia, trachea oesophageal fistula, choanal atresia, cleft palate and nasal deformities, severe cardiovascular instability. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application
2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP |
1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application
2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of babies requiring intubation in the first 72 hours of life
2. Proportion of babies who develop nasal trauma
3. Physiological variables including the mean respiratory rates and heart rates as well as Silverman’s score during the first 72 hours
4. Incidence of oxygen dependency at 28 days postnatal life, air leaks
|
Physiological variables are measured at baseline and at 1, 2, 6, 12, 18, 24 hours and every 6th hourly thereafter until 72 hours of CPAP. Nasal trauma will be graded by an independent observer daily during first 72 hours till CPAP is removed |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published 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 label parallel group single centre study comparing the efficacy and safety of CPAP delivery through nasal masks versus bi-nasal prongs in preterm babies with respiratory distress syndrome. The efficacy will be measured as the area under the curve of FiO2 requirement against time during the first 72 hours of CPAP application and safety will be measured by the incidence of nasal trauma and air leaks in both groups. |