Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001037695
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
26/09/2023
Date last updated
8/03/2024
Date data sharing statement initially provided
26/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal OXygen Immediately before birth: The MOXIE feasibility study
Scientific title
Maternal OXygen Immediately before birth: The MOXIE feasibility study
Secondary ID [1] 310344 0
N/A
Universal Trial Number (UTN)
Trial acronym
MOXIE feasibility
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal complications 331079 0
Condition category
Condition code
Reproductive Health and Childbirth 327867 327867 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maternal oxygen supplementation via heated humidified high flow nasal cannula for 5-10 minutes at 100% oxygen at 30-70L/min before umbilical cord is clamped. Adherence will be monitored in person by one of two principal investigators and will be documented in study database
Intervention code [1] 326744 0
Treatment: Devices
Comparator / control treatment
Comparator / control treatment. The historical data will be collected from records from the maternity ward in Monash Medical Center from January 2018 to December 2022
Control group
Historical

Outcomes
Primary outcome [1] 335715 0
Tolerability of humidified heated high flow nasal cannula, based on percentage of expecting mothers who complete the study protocol and their opinions of study intervention
RedCAP (Research Electronic Data Capture) for study specific questionnaire to assess opinion of study intervention.
Percentage of expecting mothers who complete the study protocol assess by audit of study records
Timepoint [1] 335715 0
At conclusion of study
Secondary outcome [1] 425277 0
Umbilical venous PaO2 via venous blood gas test
Timepoint [1] 425277 0
birth of placenta
Secondary outcome [2] 425278 0
Maternal oxygen reserve index with non invasive pulse oximeter
Timepoint [2] 425278 0
5-10 minutes before birth, to birth
Secondary outcome [3] 425279 0
Pulmonary vascular resistance via echocardiogram
Timepoint [3] 425279 0
2-4 hours after birth
Secondary outcome [4] 425280 0
Other umbilical cord blood gas parameters; pH, PaO2, PACO2, base excess
This will be assessed as a composite outcome
Timepoint [4] 425280 0
birth of placenta
Secondary outcome [5] 425281 0
APGAR (appearance, pulse, grimace, activity, respiration) scores
Timepoint [5] 425281 0
discharge of neonate
Secondary outcome [6] 426785 0
need for neonatal resuscitation (will be assessed by need for IPPV (invasive positive pressure ventilation), CPAP (continuous positive airway pressure), CPR (cardiopulmonary resuscitation), or intubation. This data will be accessed from medical records
Timepoint [6] 426785 0
discharge of neonate
Secondary outcome [7] 426786 0
Admission to NICU (neonatal intensive care unit) or SCN (special care nursery)
Data will be taken from medical records
This is a composite secondary outcome
Timepoint [7] 426786 0
Discharge of neonate

Eligibility
Key inclusion criteria
Expecting women between 32 weeks and 0 days to 41 weeks and 6 days gestational age giving birth
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of severe maternal epistaxis
History of major nasal/sinus surgery or pathology
Concurrent maternal chronic obstructive pulmonary disease (COPD) exacerbation
Fetus with congenital abnormality that would alter the expected SpO2 targets in the minutes after birth; ie antenatal diagnosis of ductal dependant cardiac lesions, congenital diaphragmatic hernia, etc.
Monochorionic twins with evidence of twin-to-twin transfusion syndrome or multiples of more than 2.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314551 0
Government body
Name [1] 314551 0
NHMRC
Country [1] 314551 0
Australia
Primary sponsor type
Individual
Name
Douglas Blank
Address
Monash Children's Hospital, 246 Clayton Rd, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 316510 0
None
Name [1] 316510 0
Address [1] 316510 0
Country [1] 316510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313589 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 313589 0
Research Support ServicesLevel 2, i Block,Monash Medical Centre246 Clayton RoadClayton VIC 3168
Ethics committee country [1] 313589 0
Australia
Date submitted for ethics approval [1] 313589 0
02/08/2023
Approval date [1] 313589 0
01/12/2023
Ethics approval number [1] 313589 0
RES-23-0000-179A

Summary
Brief summary
We aim to determine if maternal oxygen supplementation 5-10 min prior to birth of term and near-term infants (32 weeks gestation or above at birth) utilising heated humidified high flow nasal cannula with 100% oxygen at 30-70L/min is feasible at both caesarean section and vaginal births. The information gained from this feasibility study will inform the planned randomised controlled trial of maternal oxygen in very preterm infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128662 0
Dr Kan-feng Zheng
Address 128662 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 128662 0
Australia
Phone 128662 0
+61 412542799
Fax 128662 0
Email 128662 0
angela.zheng14@gmail.com
Contact person for public queries
Name 128663 0
Dr Kan-feng Zheng
Address 128663 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 128663 0
Australia
Phone 128663 0
+61 412542799
Fax 128663 0
Email 128663 0
angela.zheng14@gmail.com
Contact person for scientific queries
Name 128664 0
Dr Kan-feng Zheng
Address 128664 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 128664 0
Australia
Phone 128664 0
+61 412542799
Fax 128664 0
Email 128664 0
angela.zheng14@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.