COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001252909
Ethics application status
Approved
Date submitted
24/09/2020
Date registered
23/11/2020
Date last updated
23/11/2020
Date data sharing statement initially provided
23/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Air for Infant Resuscitation
Scientific title
The Air Study: Air for Infant Resuscitation, an observational cohort study of short term birth outcomes in mid-late preterm infants
Secondary ID [1] 301765 0
None
Universal Trial Number (UTN)
Trial acronym
AIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
premature birth 318231 0
respiratory distress 318232 0
newborn resuscitation 318233 0
Condition category
Condition code
Reproductive Health and Childbirth 316239 316239 0 0
Complications of newborn
Respiratory 316655 316655 0 0
Normal development and function of the respiratory system
Reproductive Health and Childbirth 316656 316656 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observations will be recorded by a person uninvolved in the clinical care of the infant and verified by stored data (except FiO2) on the oximeters. Variables are:

First 10 minutes -
1. Time of delivery of body
2. Time of cord clamping
3. FiO2, SpO2 and heart rate for every minute after cord clamping for 10 minutes
4. Type and timing of cardiorespiratory intervention
Prior to leaving the delivery room and at 24 hours of age -
1. Birth outcome (deceased/alive/transferred to nursery/well infant, no further medical care needed)
2. Type of cardiorespiratory support (if applicable)
3. Presence of cardiopulmonary pathology (if known).
Observations will cease at 24 hours because the majority (>80%) of newborn deaths will occur in the first day of life (WHO, n.d.). Cardiopulmonary pathology will be defined as 1. The need for supplemental oxygen to maintain SpO2 > 95% and/or 2. The need for mechanical ventilatory support after delivery room stabilization and/or 3. Structural anatomical lesions that interfere with oxygenation e.g. cyanotic heart disease. Infants will be excluded if there is no personnel to collect data or if equipment is unavailable.
References
World Health Organisation. Guidelines on basic newborn resuscitation. Available from: https://www.who.int/maternal_child_adolescent/documents/who_rht_msm_981/en/ Accessed 24 April 2020.
Intervention code [1] 318348 0
Not applicable
Comparator / control treatment
As this is an observational study comparisons will be made based upon the variables collected as described above.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324781 0
Birth outcome (alive, no further care required, transferred to nursery for further care, deceased). Assessed by research team follow up and viewing medical records.
Timepoint [1] 324781 0
Prior to leaving delivery suite
Secondary outcome [1] 385724 0
Birth outcome (alive, no further care required, transferred to nursery for further care, deceased). Assessed by research team follow up and viewing medical records.
Timepoint [1] 385724 0
At 24 hours post-delivery
Secondary outcome [2] 388155 0
Infant reaches SpO2 (>80%) targets by 5 minutes in the delivery room (yes-no)
Assessed by pulse oximetry data recording in the delivery room via Masimo oximeters
Timepoint [2] 388155 0
0-5 minutes of life.

Eligibility
Key inclusion criteria
Any live born infant >= 32 weeks gestation requiring respiratory support
Respiratory support is defined as:
: 1. the need for supplemental oxygen and/or positive pressure ventilation to maintain SpO2 > 95% after stabilization and/or 2. The need for mechanical ventilatory support after delivery room stabilization and/or 3. Structural anatomical lesions that interfere with oxygenation e.g. cyanotic heart disease.
Minimum age
32 Weeks
Maximum age
36 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of personnel or appropriate equipment (including oximetry and oxygen blenders) to record data

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We aim to recruit 2% of total births in the participating hospitals across the study period. 10% are expected to require intervention at birth, including positive pressure ventilation with oxygen. Funding, ethics approval and practical constraints throughout the COVID-19 pandemic will impact on the feasibility of the target sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17629 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 17630 0
St George Hospital - Kogarah
Recruitment hospital [3] 17631 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 17632 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 17633 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 17634 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 17635 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 31375 0
2031 - Randwick
Recruitment postcode(s) [2] 31376 0
2217 - Kogarah
Recruitment postcode(s) [3] 31377 0
2305 - New Lambton
Recruitment postcode(s) [4] 31378 0
2560 - Campbelltown
Recruitment postcode(s) [5] 31379 0
2148 - Blacktown
Recruitment postcode(s) [6] 31380 0
2145 - Westmead
Recruitment postcode(s) [7] 31381 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 22845 0
Malaysia
State/province [1] 22845 0
Country [2] 22846 0
Singapore
State/province [2] 22846 0
Country [3] 22847 0
China
State/province [3] 22847 0
Country [4] 22848 0
India
State/province [4] 22848 0
Country [5] 22849 0
Indonesia
State/province [5] 22849 0
Country [6] 22850 0
Viet Nam
State/province [6] 22850 0
Country [7] 22851 0
Spain
State/province [7] 22851 0
Country [8] 22852 0
Guatemala
State/province [8] 22852 0
Country [9] 22853 0
Canada
State/province [9] 22853 0
Country [10] 22854 0
United States of America
State/province [10] 22854 0

Funding & Sponsors
Funding source category [1] 306196 0
Self funded/Unfunded
Name [1] 306196 0
Unfunded
Address [1] 306196 0
Country [1] 306196 0
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 306670 0
University
Name [1] 306670 0
University of New South Wales
Address [1] 306670 0
High St, UNSW Sydney NSW 2052
Country [1] 306670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306407 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 306407 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 306407 0
Australia
Date submitted for ethics approval [1] 306407 0
28/04/2020
Approval date [1] 306407 0
20/05/2020
Ethics approval number [1] 306407 0
2020/ETH01038

Summary
Brief summary
AIR is an observational study that aims to determine if oxygen saturations (SpO2) of newborn infants above 32 weeks gestation can reach recommended levels suggested by international expert guidelines.

Currently, international guidelines recommend that respiratory support for newborn infants at or above 35 weeks gestation and those between 32-34 weeks gestation be initiated with air (21% oxygen) and 21-30% oxygen, respectively. For the first 10 minutes of life, guidelines also recommend that the amount of oxygen given to the infants should be adjusted to target SpO2 of healthy, full-term infants.

This is part of an international multicentre study of >40 hospitals in >10 countries. We anticipate that each centre will provide ~2% of total births to achieve the target sample of 5,000 infants within 3 years (total births > 300,000 from Australian and international sites).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103778 0
A/Prof Ju-Lee Oei
Address 103778 0
Royal Hospital for Women, Barker St
Randwick NSW 2031
Country 103778 0
Australia
Phone 103778 0
+61293826152
Fax 103778 0
+61293826191
Email 103778 0
j.oei@unsw.edu.au
Contact person for public queries
Name 103779 0
Mr James Sotiropoulos
Address 103779 0
Royal Hospital for Women, Barker St
Randwick NSW 2031
Country 103779 0
Australia
Phone 103779 0
+61452488303
Fax 103779 0
Email 103779 0
james.sotiropoulos@gmail.com
Contact person for scientific queries
Name 103780 0
A/Prof Ju-Lee Oei
Address 103780 0
Royal Hospital for Women, Barker St
Randwick NSW 2031
Country 103780 0
Australia
Phone 103780 0
+61293826152
Fax 103780 0
+61293826191
Email 103780 0
j.oei@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be made available to researchers as detailed below
When will data be available (start and end dates)?
No end date determined. IPD available after publication.
Available to whom?
Researchers who provide methodologically sound and compatible proposals with confirmed ethics approval. Consent waiver should be included in the aforementioned ethics approval.
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Contact via email the research team. Primary contact james.sotiropoulos@student.unsw.edu.au
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8802 0
Ethical approval
Citation [1] 8802 0
Link [1] 8802 0
Email [1] 8802 0
Other [1] 8802 0
2020/ETH01038 via NSW Health Ethics (REGIS)
Approved by HNE Ethics 20/5/2020
Attachment [1] 8802 0
Type [2] 8803 0
Study protocol
Citation [2] 8803 0
Link [2] 8803 0
Email [2] 8803 0
Other [2] 8803 0
As per attachment
Type [3] 9526 0
Statistical analysis plan
Citation [3] 9526 0
Link [3] 9526 0
Email [3] 9526 0
Other [3] 9526 0
Summary results
No Results