| CTRI Number |
CTRI/2021/03/032409 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
29/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare two different nasal interfaces for non-invasive ventilation support of preterm infants with respiratory distress in a tertiary care hospital |
|
Scientific Title of Study
|
Randomized control trial comparing two different nasal interfaces for non-invasive ventilation support of preterm with respiratory distress syndrome in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Anand |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pediatrics
SMGS Hospital
Government Medical College,
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
07006396760 |
| Fax |
|
| Email |
amt.anand101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Bhatti |
| Designation |
Associate Professer |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pediatrics
SMGS Hospital
Government Medical College,
Jammu
Jammu
JAMMU & KASHMIR
180005
India |
| Phone |
9419221115 |
| Fax |
|
| Email |
bhatti.anuj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Bhatti |
| Designation |
Associate Professer |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pediatrics
SMGS Hospital
Government Medical College,
Jammu
Jammu
JAMMU & KASHMIR
180005
India |
| Phone |
9419221115 |
| Fax |
|
| Email |
bhatti.anuj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics
Government Medical College, Jammu |
|
|
Primary Sponsor
|
| Name |
Dr Anuj Bhatti |
| Address |
Associate Professor,
Department of Pediatrics,
Government Medical College, Jammu |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuj Bhatti |
Government Medical College, Jammu |
NICU, Department of Pediatrics
Jammu
JAMMU & KASHMIR |
9419221115
bhatti.anuj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College, Jammu Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RAM cannula |
In the experimental group, RAM cannula will be used a nasal interface in a stand-alone Bubble CPAP device (Bubble CPAP system with F & P nasal interface—BC 163, Fisher and Paykel Healthcare, Panmure, Auckland, New Zealand). For infants on RAM cannula, cannula size was chosen which best fits the nares and fills nearly 80% of nares. Cannulaide of appropriate size or tegaderm dressing will be used to prevent any possible leak around the nares with RAM cannula. |
| Comparator Agent |
Short Binasal Prongs |
: In the standard group, short binasal prongs (Fisher and Paykel Healthcare) will be used a nasal interface in a stand-alone Bubble CPAP device (Bubble CPAP system with F & P nasal interface—BC 163, Fisher and Paykel Healthcare, Panmure, Auckland, New Zealand). |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1) Inborn babies with gestational age between
28weeks to 34weeks and birth weight more than or
equal to 1000 g.
2) The presence of respiratory distress (presence of at least two out of three signs: tachypnoea > 60 per minute, intercostal retractions and
expiratory grunt) within 6h of life requiring
nasal CPAP.
|
|
| ExclusionCriteria |
| Details |
1) Intubation soon after birth
2) APGAR score ≤3
3) Life threatening malformations such as
congenital diaphragmatic hernia, trachea-
oesophageal fistula, and malformations that
would prevent establishment of CPAP due to the
anatomical defect such as Pierre- Robinson
syndrome and choanal atresia.
4) Conditions where intubation and mechanical
ventilation are directly indicated such as
apnea and hypotensive shock.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Failure of CPAP within first 72 hrs of life |
first 72 hrs of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CPAP failure |
7 days |
| Need for intubation and mechanical ventilation |
72 hours of life |
| Remained on CPAP by 72 h of age |
72 hours |
| Remained on CPAP by 7 days of age |
7 days |
| Total duration of CPAP in hours |
hours |
| Maximum CPAP pressure (cm H20) |
72 hours |
| Surfactant (post randomization) |
hours |
| Nasal injury score |
0-7 |
| Suspected sepsis |
during hospitalization |
| Culture proven sepsis |
during the hospitalization |
| Necrotizing enterocolitis |
Stage 2 and 3 during hospitilization |
Intraventricular hemorrhage
(greater than grade 1) |
during hospitalization |
| Pneumothorax |
during hospitalization |
| Pulmonary hemorrhage |
any time during hospitalization |
| Bronchopulmonary dysplasia |
by 36 weeks post menstrual age |
| Feeding intolerance |
any time during hospitalization |
| death |
during hospital stay |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2021 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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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 two different nasal interfaces for non-invasive ventilation support in preterm infants with respiratory distress in a tertiary care hospital. The primary outcome measure will be failure of CPAP(Continuous positive airway pressure) within 72 hours of life. The secondary outcomes were: failure of CPAP by 7 days of age, proportion of infants who received post-randomization surfactant, total duration of CPAP, incidence of death during hospital stay, pnemothorax, blood culture positive sepsis (systemic evidence of infection along with a positive blood culture), Bronchopulmonary dysplasia (need for supplemental oxygen at 36 weeks postmenstrual age), intraventricular
hemorrhage (grade 2 and above), periventricular leucomalacia (any grade), and necrotizing enterocolitis (stages 2 and 3).
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