| CTRI Number |
CTRI/2024/09/073879 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [No application of CPAP in late preterm and term neonates with mild respiratory distress at birth] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"CPAP vs. No-CPAP: Which is Better for Newborns with Mild Breathing Issues?" |
|
Scientific Title of Study
|
No-CPAP versus CPAP in late preterm and term neonates with mild respiratory distress: A non-inferiority parallel group open-label randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritesh Ranjan Sah |
| Designation |
Senior Resident |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9872311374 |
| Fax |
|
| Email |
sahritesh1108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Sachdeva |
| Designation |
Additional Professor |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Room no 801, C wing, 8th floor, Mother and Child block, Division of
Neonatology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110049
India
South
DELHI
110049
India |
| Phone |
9891392188 |
| Fax |
|
| Email |
dranuthukral@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Ranjan Saha |
| Designation |
Senior Resident |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9872311374 |
| Fax |
|
| Email |
sahritesh1108@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, New Delhi |
| Address |
Ansari Nagar East, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Anu Sachdeva |
All India Institute of Medical Sciences, New Delhi |
Neonatal Intensive Care unit, MCB NICU first floor
Department of
Pediatrics, AIIMS, New
Delhi
South
South
DELHI |
9891392188
dranuthukral@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P221||Transient tachypnea of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CPAP |
Late pre-term (34 weeks 0/7 days to 36 weeks 6/7 days of gestation) and term neonates (37 weeks 0/7 days to 41 weeks 6/7 days of gestation) with mild respiratory distress at birth, defined as Silverman-Andersson score of 1-3 will be included in the study. The neonates will be randomized into two groups at 10 to minutes of life. The second group will receive CPAP support. The neonates will be monitored every 15 minutes for first 1 hour. At 1 hour of life, neonate having any distress defined as Silverman-Andersson score ≥1 or requirement of supplemental oxygen will be admitted to NICU.
In the NICU the respiratory support will be hiked in case of any increase in respiratory distress. Supplemental oxygen will be provided in case of hypoxia defined as oxygen saturation less than 91%. The respiratory support will be removed after resolution of respiratory distress (Silverman-Andersson score of 0) and the oxygen saturation is in normal range (more than equal to 91%) in absence of supplemental oxygen. The neonate will be considered off respiratory support if there will be no further requirement of CPAP support/supplemental oxygen for 24 hours after removal of respiratory support.
|
| Intervention |
No-CPAP |
Late pre-term (34 weeks 0/7 days to 36 weeks 6/7 days of gestation) and term neonates (37 weeks 0/7 days to 41 weeks 6/7 days of gestation) with mild respiratory distress at birth, defined as Silverman-Andersson score of 1-3 will be included in the study. The neonates will be randomized into two groups at 10 to 15 minutes of life. The first group will receive No-CPAP support. The neonates will be monitored every 15 minutes for first 1 hour. At 1 hour of life, neonate having any distress defined as Silverman-Andersson score ≥1 or requirement of supplemental oxygen will be admitted to NICU.
In the NICU the respiratory support will be hiked in case of any increase in respiratory distress. Supplemental oxygen will be provided in case of hypoxia defined as oxygen saturation less than 91%. The respiratory support will be removed after resolution of respiratory distress (Silverman-Andersson score of 0) and the oxygen saturation is in normal range (more than equal to 91%) in absence of supplemental oxygen. The neonate will be considered off respiratory support if there will be no further requirement of CPAP support/supplemental oxygen for 24 hours after removal of respiratory support. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Late pre-term (34 weeks,0/7 days to 36 weeks,6/7 days of gestation) and term neonates (37 weeks, 0/7 to 41 weeks 6/7 days of gestation) with mild respiratory distress defined as Silverman-Anderson score of 1-3 at birth |
|
| ExclusionCriteria |
| Details |
1.Requirement of positive pressure ventilation for more than 30 seconds at birth
2.Perinatal asphyxia – Apgar score of less than 7 at one minute of life
3.Babies born with meconium-stained liquor
4.Maternal chorioamnionitis
5.Suspected or known major congenital malformation or any malformation that interferes with intervention and outcome
6.Requirement of NICU admission for any cause other than transient tachypnea of newborn
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of respiratory support in late-preterm and term neonates with mild respiratory distress, managed with No-CPAP vs. CPAP in the delivery room at birth |
From institution to removal of respiratory support |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for neonatal intensive care unit (NICU) admission |
From randomization to decision for neonatal intensive care unit (NICU) admission |
| Escalation of respiratory support |
From randomization to shifting out of neonatal intensive care unit (NICU) |
| Incidence of air leak e.g. pneumothorax |
From randomization to discharge from hospital |
| Duration of neonatal intensive care unit (NICU) stay |
Total duration of NICU stay calculated from NICU admission to shifting out of NICU |
| Duration of hospital stay |
Total duration of hospital stay calculated from day of birth to the day of hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
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)
|
16/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Late pre-term (34 weeks, 0/7 days to 36 weeks, 6/7 days of gestation) and term neonates (37 weeks 0/7 days to 41 weeks 6/7 days of gestation) with mild respiratory distress defined as Silverman-Andersson score of 1-3 will be included in the study. The neonates will be randomized into two groups at 10 to 15 minutes of life. The first group will receive No-CPAP support and the second group will receive CPAP support. The positive end expiratory pressure (PEEP) will be applied at 5 cm of water (in CPAP group only) to begin with. The neonates will be monitored every 15 minutes for first 1 hour. At 1 hour of life, neonate from both the groups having any distress defined as Silverman-Andersson score ≥1 or requirement of supplemental oxygen will be admitted to NICU. If any neonate at or earlier than 1 hour of life will have respiratory deterioration, with Silverman-Andersson score of ≥4, will be admitted to NICU and managed according to protocol. |