| CTRI Number |
CTRI/2025/09/094952 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to compare different oxygen concentrations administered during birth resuscitation of preterm neonates |
|
Scientific Title of Study
|
Initial Oxygen For Delivery Room Resuscitation Of Preterm Neonates: A Triple-arm, Multi-site, Randomised, Controlled Trial |
| Trial Acronym |
PORTAL - Preterm Oxygen for Resuscitation Trial At deLivery |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkataseshan Sundaram |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Neonatology, Department of Pediatrics
Chandigarh
CHANDIGARH
160012
India |
| Phone |
2755340 |
| Fax |
|
| Email |
venkatpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkataseshan Sundaram |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Neonatology, Department of Pediatrics
CHANDIGARH
160012
India |
| Phone |
2755340 |
| Fax |
|
| Email |
venkatpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkataseshan Sundaram |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Neonatology, Department of Pediatrics
CHANDIGARH
160012
India |
| Phone |
2755340 |
| Fax |
|
| Email |
venkatpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Ansari Nagar, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Venkataseshan Sundaram |
| Address |
Professor, Division of Neonatology, Department of Pediatrics,
Level 3, F block, Nehru Hospital, PGIMER, Sector 12, Chandigarh, 160012 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reeta Bora |
Assam Medical College |
Department of Pediatrics, Main building, Barbari, Dibrugarh, 786002
Dibrugarh
ASSAM |
9435394313
bora64reeta@gmail.com |
| Manikumar S |
Chengalpattu Medical College |
Department of Neonatology, Old OP Block, GST Road, CMC and Hospital Chengalpattu, Kancheepuram, 603001
Kancheepuram
TAMIL NADU |
9841781037
dr_manikumars@yahoo.co.in |
| Deepak Chawla |
Government Medical College and Hospital |
Department of Neonatology, Block A, Level I, GMCH, Sector 32, Chandigarh, 160031
Chandigarh
CHANDIGARH |
9646121559
drdeepak.chawla@gmail.com |
| Lakshmikant Deshmukh |
Government Medical College and Hospital |
Department of Neonatology, Second floor, Surgical building, pancake Road, Jubilee Park, Chhatrapati Sambhaji nagar, Aurangabad, 431001
Aurangabad
MAHARASHTRA |
9822478275
deshmukhls@yahoo.com |
| Mangalabharathi Sundaram |
Institute of Obstetrics and Gynecology |
Department of Neonatology, IOG building, Halls Road, Egmore, Chennai, 600008
Chennai
TAMIL NADU |
9840786836
drmangalabharathi@gmail.com |
| Venkataseshan Sundaram |
Post Graduate Institute of Medical Education and Research |
Division of Neonatology, Department of Pediatrics, Level 3, F block, Nehru Hospital, PGIMER, Sector 12
Chandigarh
CHANDIGARH |
9478001129
venkatpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH, Chandigarh) |
Approved |
| Institutional Ethics Committee (H), Assam Medical College, Dibrugarh |
Approved |
| Institutional Ethics Committee (IEC-GMCA) |
Approved |
| Institutional Ethics Committee, Chengalpattu Medical College |
Approved |
| Institutional Ethics Committee, Madras Medical College, Chennai |
Approved |
| Institutional Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE], (2) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, (3) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Initial resuscitation with 30% initial FiO2 by T-piece |
Resuscitation with 30% initial FiO2 by T-piece till a reliable recording of preductal pulse oxygen saturation is available followed by oxygen titration based on published saturation targets. The comparator oxygen concentration will be given till the neonates needs resuscitation which will be for a maximum period of 20 minutes from birth. |
| Intervention |
Initiating resuscitation with 60% initial FiO2 by T-piece |
Resuscitation with 60% initial FiO2 by T-piece till a reliable recording of preductal pulse oxygen saturation is available followed by oxygen titration based on published saturation targets. The intervention oxygen concentration will be given till the neonates needs resuscitation which will be for a maximum period of 20 minutes from birth. |
| Intervention |
Initiating resuscitation with 90% initial FiO2 by T-piece |
Resuscitation with 90% initial FiO2 by T-piece till a reliable recording of preductal pulse oxygen saturation is available followed by oxygen titration based on published saturation targets. The intervention oxygen concentration will be given till the neonates needs resuscitation which will be for a maximum period of 20 minutes from birth. |
|
|
Inclusion Criteria
|
| Age From |
0.10 Day(s) |
| Age To |
0.20 Day(s) |
| Gender |
Both |
| Details |
Consecutively born preterm neonates of less than 32 completed weeks of gestation and requiring delivery room (DR) resuscitation with positive pressure ventilation (PPV) as per the most recent neonatal resuscitation program (NRP) guidelines will be included. |
|
| ExclusionCriteria |
| Details |
• Pregnant women with insufficient time during the antenatal period to administer and obtain an informed consent
• Antenatally suspected or proven major structural anomalies (those responsible for death, morbidities and disability related to congenital anomalies - as per CDC definition)
• Parental request or neonatologist decision to forego resuscitation
• Refusal of consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A composite of all-cause mortality or bronchopulmonary dysplasia with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier. |
Death or 44 weeks post-menstrual age, whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A composite of all-cause mortality or bronchopulmonary dysplasia or retinopathy of prematurity requiring treatment or necrotising enterocolitis (definite or advanced stages) or brain injury (major intra-ventricular hemorrhage or periventricular leukomalacia) with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier. |
Death or 44 weeks post-menstrual age, whichever is earlier. |
| Structural changes in brain as assessed by MRI brain. |
44 weeks PMA (term equivalent age). |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
01/11/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 [venkatpgi@gmail.com].
- For how long will this data be available start date provided 16-09-2025 and end date provided 15-09-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale & gaps in knowledge: The appropriate initial oxygen concentration (FiO2) for delivery room (DR) resuscitation in preterm neonates is unclear. ILCOR recommends 21-30% based on weak evidence. A recent Individual Participant Data meta-analysis reported reduced mortality in greater than 90% oxygen arm compared to 21-30% and 50-65% arms. Novelty: • Triple-armed, blinded, multisite, randomized trial. • Patient-centric composite hard outcomes. Objectives: • To compare 90% or 60% FiO2 with 30% FiO2 for initial delivery room resuscitation of very preterm neonates in reduction of death or broncho-pulmonary dysplasia. • To compare 90% or 60% FiO2 with 30% FiO2 for initial resuscitation of very preterm neonates in reduction of a composite adverse outcome. • To compare the MRI brain changes in a subset of very preterm neonates resuscitated with an initial FiO2 of 90%, 60% or 30%. Methods: Consecutive inborn very preterm neonates requiring DR resuscitation will be randomly allocated (stratified by gestation and study-site) to 30%, 60% or 90% initial FiO2. The FiO2 shall be masked from the resuscitating team and outcome assessors. Death or BPD by 44 weeks PMA will be the primary outcome. A composite adverse outcome (Death or BPD or ROP or NEC or brain injury at 44-weeks PMA) will be the secondary outcome. MRI brain at 44-weeks PMA will be done in a subset of 25%. Analysis: ITT and per protocol, adjustment ‘a priori’ covariates - weight, antenatal steroids, and antenatal magnesium sulfate. Expected outcomes: • Evidence based recommendations for initial FiO2 for delivery room resuscitation of very preterm neonates. |