| CTRI Number |
CTRI/2012/04/002593 [Registered on: 20/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2012 |
| 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
|
COMPARISON OF USING AIR VERSUS 100% OXYGEN FOR MANAGING NEWLY BORN BABIES IN THE DELIVERY ROOM |
|
Scientific Title of Study
|
DELIVERY ROOM RESUSCITATION OF PRETERM NEONATES WITH ROOM AIR VERSUS 100 % OXYGEN: A BLINDED RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
L Nishath Ahmed |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
Newborn unit, Dept of Pediatrics
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755308 |
| Fax |
01722744401 |
| Email |
drlnishathahmed@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
S Venkataseshan |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Newborn unit, Dept of Pediatrics
PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755340 |
| Fax |
01722744401 |
| Email |
venkatpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Kumar |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Newborn unit, Dept of Pediatrics
PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755308 |
| Fax |
01722744401 |
| Email |
drpkumarpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12, Chandigarh |
| 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 Praveen Kumar |
Newborn unit, Department of Pediatrics, PGIMER, Chandigarh, India |
Newborn unit, Department of Pediatrics,PGIMER, Sector 12-160012
Chandigarh
CHANDIGARH |
01722755308
01722744401
drpkumarpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The oxidative stress levels, by measuring plasma 15-F2t-isoprostane levels with and without exposure to 100% oxygen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
100% oxygen |
Administered in delivery room if resuscitation is warranted till the babys pulse saturation is within the normal range for that age |
| Comparator Agent |
Room air |
21% of oxygen, administered in delivery room if resuscitation is warranted |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
0.00 Day(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1) Preterm neonates 28 to 33 6/7 weeks gestation born between 8 AM to 9PM , Monday to Saturday in delivery room or operation theatre (Note: These timings have been chosen to ensure the availability of the research team for all eligible deliveries ), and
2) Needing bag and mask ventilation as per Neonatal Resuscitation Program (NRP) i.e. apnea or gasping respiration, and/or heart rate < 100/min after 30 seconds of initial steps
Exclusion criteria:
1)Life threatening congenital malformations diagnosed antenatally or soon after birth
2)Antenatally diagnosed congenital heart defects
3)Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.
|
|
| ExclusionCriteria |
| Details |
a) Life threatening congenital malformations diagnosed antenatally or soon after birth
b) Antenatally diagnosed congenital heart defects
c) Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plasma 15-F2t-isoprostane levels |
At 4 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Biochemical : Plasma 15-F2t-isoprostane levels, plasma MDA levels, blood gas parameters (pH, pO2, pCO2, SBE)
b) Physiologic : Apgar scores at 5, 10, 15 and 20 minutes of life, Time to normalization of heart rate (>100/minute), heart rate and SpO2 changes
c) Clinical : Time to first breath, Time to achieve regular respiration, Mortality, Incidences of hypoxic ischemic encephalopathy (HIE), Bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP), duration of oxygen, duration of ventilation, abnormal neurological examination
|
Biochemical - 1, 4, 12, 24 and 72 hours
Physiologic - 30 minutes
Clinical - 40 weeks or earlier |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
04/10/2010 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled trial with blinding in preterm neonates 28 to 33 6/7 weeks gestation needing resuscitation at birth to study whether resuscitating them with room air (21% oxygen) decrease the plasma 15-F2t-isoprostane levels (measure of oxidative stress) at 4 hours of life by at least 30% in comparison to 100% oxygen. This study will be conducted in a single center in India and has planned to enroll 124 preterm neonates for this purpose after obtaining an informed written consent. The primary outcome measure will be Plasma 15-F2t-isoprostane levels at 4 hours of life. The major secondary outcomes will be Plasma 15-F2t-isoprostane levels at 72 hours of life, MDA levels at 4 hrs and 72 hours of life, Blood gas parameters (pH, pO2, pCO2, SBE) at 1,4,12 and 24 hours of life, Apgar scores at 5, 10, 15 and 20 minutes of life, Time to normalization of heart rate (>100/minute), heart rate and SpO2 changes in first 30 minutes of life, Time to first breath, Time to achieve regular respiration, Mortality till 40 weeks of postmenstrual age, Incidences of hypoxic ischemic encephalopathy (HIE), Bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP), duration of oxygen, duration of ventilation, abnormal neurological examination at 40 weeks of postmenstrual age. |