Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001177640p
Ethics application status
Submitted, not yet approved
Date submitted
1/10/2023
Date registered
14/11/2023
Date last updated
14/11/2023
Date data sharing statement initially provided
14/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal high-flow during deferred cord clamping in very preterm infants
Scientific title
Nasal high-flow during deferred cord clamping in very preterm infants: a pilot feasibility study
Secondary ID [1] 310717 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity
 331652 0
Condition category
Condition code
Respiratory 328373 328373 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 328668 328668 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. Nasal high-flow is currently used in preterm infants with respiratory distress soon after birth. Nasal high-flow will be provided to very preterm infants immediately after birth, aiming for a minimum duration of 60 and maximum duration of 120 seconds if good tone and respirations, consistent with local guidelines at the Royal Women's Hospital.
A research team member (neonatal consultant or fellow) will be administering the intervention (applying the high flow).
Intervention code [1] 327115 0
Treatment: Other
Comparator / control treatment
Nasal high-flow therapy during deferred cord clamping will be compared with standard care (no nasal high-flow therapy or other breathing support during deferred cord clamping).
Control group
Active

Outcomes
Primary outcome [1] 336214 0
Feasibility of providing nasal high-flow during deferred cord clamping
Timepoint [1] 336214 0
At completion of delivery room stabilisation
Secondary outcome [1] 427357 0
Duration of cord clamping (in seconds)
Timepoint [1] 427357 0
At time of cord clamping
Secondary outcome [2] 427358 0
Proportion of infants achieving >60 seconds deferred cord clamping
Timepoint [2] 427358 0
At conclusion of study.
Secondary outcome [3] 427359 0
Provision of positive pressure ventilation in the delivery room
Timepoint [3] 427359 0
Delivery room stabilisation
Secondary outcome [4] 427360 0
Duration of positive pressure ventilation in the delivery room (in seconds)
Timepoint [4] 427360 0
Delivery room stabilisation
Secondary outcome [5] 427361 0
Intubation in the delivery room
Timepoint [5] 427361 0
Delivery room stabilisation
Secondary outcome [6] 427362 0
Maximum FiO2 in the delivery room
Timepoint [6] 427362 0
Delivery room stabilisation
Secondary outcome [7] 427363 0
Heart rate 2-5 minutes after birth
Timepoint [7] 427363 0
2-5 minutes after birth
Secondary outcome [8] 427364 0
Oxygen saturation 2-5 minutes after birth
Timepoint [8] 427364 0
2-5 minutes after birth
Secondary outcome [9] 427365 0
Temperature at 10 minutes after birth
Timepoint [9] 427365 0
10 minutes after birth
Secondary outcome [10] 427366 0
Apgar score at 1 minute
Timepoint [10] 427366 0
1 minute after birth
Secondary outcome [11] 427367 0
Apgar score at 5 minutes
Timepoint [11] 427367 0
5 minutes after birth
Secondary outcome [12] 427368 0
Mode of respiratory support upon leaving the delivery room
Timepoint [12] 427368 0
Upon leaving the delivery room
Secondary outcome [13] 427369 0
FiO2 upon leaving the delivery room
Timepoint [13] 427369 0
Upon leaving the delivery room
Secondary outcome [14] 427370 0
Pneumothorax requiring drainage
Timepoint [14] 427370 0
Within 24 hours after birth
Secondary outcome [15] 427371 0
Hypothermia < 36°C in the delivery room
Timepoint [15] 427371 0
In the delivery room
Secondary outcome [16] 427372 0
Grade III/IV intraventricular haemorrhage (IVH)
Timepoint [16] 427372 0
Within 72 hours after birth
Secondary outcome [17] 427373 0
Death within 72 hours after birth
Timepoint [17] 427373 0
Within 72 hours after birth

Eligibility
Key inclusion criteria
Very preterm infants born 26-31+6 weeks’ gestation born at the Royal Women’s Hospital, where prospective, written consent has been obtained from the parent/legal guardian.
Minimum age
No limit
Maximum age
1 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contraindication to deferred cord clamping, including monochorionic twin pregnancy, large antepartum haemorrhage, vasa praevia or placental abruption, general anaesthetic, cord prolapse
• Contraindication to nasal high-flow (congenital diaphragmatic hernia, abdominal wall defect, nasal abnormality, craniofacial abnormality involving nose/mouth, cyanotic congenital heart disease)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by REDCap randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
Date of last participant enrolment
Anticipated
7/07/2025
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25608 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 41433 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 314932 0
Hospital
Name [1] 314932 0
Royal Women's Hospital
Country [1] 314932 0
Australia
Funding source category [2] 315148 0
Charities/Societies/Foundations
Name [2] 315148 0
Royal Australasian College of Physicians
Country [2] 315148 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
20 Flemington Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 316938 0
None
Name [1] 316938 0
Address [1] 316938 0
Country [1] 316938 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313923 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 313923 0
Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Ethics committee country [1] 313923 0
Australia
Date submitted for ethics approval [1] 313923 0
06/09/2023
Approval date [1] 313923 0
Ethics approval number [1] 313923 0

Summary
Brief summary
Deferred (delayed) cord clamping for at least 60 seconds improves survival in very preterm infants. However, some infants require positive pressure ventilation to establish breathing in the first minutes after birth. For these infants, the cord is often clamped early, therefore they miss out on the benefits of deferred cord clamping. Furthermore, positive pressure ventilation may injure the fragile preterm lung. Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. We hypothesise that the provision of nasal high-flow prior to cord clamping may support and stimulate breathing, therefore allowing deferred cord clamping to occur and limiting positive pressure ventilation, improving outcomes. In this single-centre pilot randomised trial, preterm infants born 26-31+6 weeks’ gestation will be randomised 1:1 to nasal high-flow during deferred cord clamping, or to standard care (no nasal high-flow or other respiratory support, deferred cord clamping only). We aim to study the feasibility of providing nasal high-flow prior to cord clamping in 50 infants with respect to 1) acceptability to clinicians and 2) practical application. We will also study clinical and physiological outcomes in infants receiving nasal high-flow during deferred cord clamping, compared with those receiving standard care. These pilot data will help establish feasibility for a larger randomised controlled trial, and inform the primary outcome and sample size for this definitive trial.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 129806 0
Dr Kate Hodgson
Address 129806 0
Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129806 0
Australia
Phone 129806 0
+61 407567360
Fax 129806 0
Email 129806 0
kate.hodgson@thewomens.org.au
Contact person for public queries
Name 129807 0
Dr Kate Hodgson
Address 129807 0
Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129807 0
Australia
Phone 129807 0
+61 407567360
Fax 129807 0
Email 129807 0
kate.hodgson@thewomens.org.au
Contact person for scientific queries
Name 129808 0
Dr Kate Hodgson
Address 129808 0
Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129808 0
Australia
Phone 129808 0
+61 407567360
Fax 129808 0
Email 129808 0
kate.hodgson@thewomens.org.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?
Outcome data
When will data be available (start and end dates)?
For 5 years after publication
Available to whom?
Requests will be evaluated by the Trial Steering Committee
Available for what types of analyses?
To be evaluated by Trial Steering Committee
How or where can data be obtained?
By request emailed to PI- Kate Hodgson (Kate.Hodgson@thewomens.org.au)


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.