| CTRI Number |
CTRI/2023/01/048958 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
18/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Suitable oxygen levels to help small babies to breathe at birth |
|
Scientific Title of Study
|
Optimum Oxygen Concentration for Initiation of Delivery Room Stabilization in Preterm Neonates: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/22/612/23/12/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonu Kumar |
| Designation |
Academic Senior Resident (DM Neonatology) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016113 Block A, Medical College Building, Department of
Pediatrics, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9416593940 |
| Fax |
|
| Email |
9416593940s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh Virbhadra Road, Pashulok, District - Dehradun
Uttarachal – 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Rishikesh Virbhadra Road,
Pashulok, District - Dehradun Uttarachal – 249203
|
| 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 |
| Sriparna Basu |
All India Institute of Medical Sciences, Rishikesh |
Labor Room Complex
and Obstetric Operation
Theater Level 3, B
Block, Hospital
Building, Department of
Gyne and Obstetrics
and Labor Room
Nursery and Neonatal
Intensive Care Unit
Level 3, B Block,
Hospital Building,
Department of
Neonatology
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL |
9935340260
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P019||Newborn affected by maternal complication of pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Initiation of delivery room stabilization with 30% oxygen followed by subsequent titration to achieve pre-defined oxygen saturation targets |
Preterm neonates of gestational age 34 weeks requiring respiratory support for delivery room stabilization as per AHA-NRP 2020 guidelines, oxygen support will be started at 30% and will be subsequently titrated by 10% every 30 seconds to achieve oxygen saturation targets defined by American Heart Association Neonatal Resuscitation Program (AHA-NRP) 2020 guidelines for immediate postnatal transition. |
| Intervention |
Initiation of delivery room stabilization with 60% oxygen followed by subsequent titration to achieve pre-defined oxygen saturation targets |
Preterm neonates of gestational age 34 weeks requiring respiratory support for delivery room stabilization as per AHA-NRP 2020 guidelines, oxygen support will be started at 60% and will be subsequently titrated by 10% every 30 seconds to achieve oxygen saturation targets defined by American Heart Association Neonatal Resuscitation Program (AHA-NRP) 2020 guidelines for immediate postnatal transition. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Inborn preterm neonates with gestational age less than 34 weeks requiring respiratory support for delivery room stabilization as per American Heart Association Neonatal Resuscitation Program (AHA-NRP) 2020 guidelines. |
|
| ExclusionCriteria |
| Details |
1. Neonates with birth weight <500 grams and gestational age <25 weeks
2. Non availability of oxygen blender at delivery area
3. Major congenital anomalies
4. Inability to obtain parental consent
5. Parental decision - not to resuscitate
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of neonates achieving a target oxygen saturation of ≥80%. |
At 5 minutes of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to achieve HR100/min
2. Time to achieve SpO2 85%
3. Heart rate and SpO2 at different time intervals
4. Cerebral regional oxygen saturation (crSO2) at 1 hour of life
5. Need for delivery room intubation
6. Need for surfactant use
7. Need and duration of respiratory support
8. Duration of supplemental oxygen therapy
9. Duration of hospital stay
10. Final outcome
11. Incidence of adverse events
|
During hospital stay and at discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sriparna.neonat@aiimsrishikesh.edu.in].
- For how long will this data be available start date provided 02-06-2026 and end date provided 02-06-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Aim of the study: To compare the effect of two different oxygen concentrations, i.e., 30% vs. 60% for initiation of delivery room stabilization in preterm neonates.
Hypothesis: The present study is planned with a hypothesis that initiating delivery room stabilization with an oxygen concentration of 60% might increase the proportion of preterm neonates achieving a target oxygen saturation of ≥80% at 5 minutes, compared to an oxygen concentration of 30%, and lead to a better outcome. The present study may help to generate evidence for the use of optimal initial oxygen concentration for stabilizing preterm neonates at birth. |