ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000790448p

Ethics application status

Submitted, not yet approved

Date submitted

6/01/2025

Date registered

25/07/2025

Date last updated

25/07/2025

Date data sharing statement initially provided

25/07/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Baby-Breathing with non-Invasive Respiratory support During Deferred umbilical cord clamping (A feasibility study).

Scientific title

Baby-Breathing with non-Invasive positive pressure ventilation support during Deferred umbilical cord clamping. (A feasibility study).

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Baby-BIRD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal transition

Neonatal resuscitation

Umbilical cord clamping

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Establishment of ventilation, either via positive pressure ventilation or effective spontaneous breathing, prior to umbilical cord clamping, as detailed below.
We will provide humidified nasal CPAP once the baby is born prior to the umbilical cord being clamped. This will be commenced at 8cmH2O and an FiO2 of 0.3. If the baby is not breathing whist receiving CPAP than nasal NIMV will be commenced by a ventilator or by a T-piece which will be part of the circuit. Positive pressure will be commenced at 25cm of H20 as per standard resuscitation guidelines and can be increased per the discretion of the user. We will delay clamping of the umbilical cord until at least 180 seconds until a maximum of 300 seconds however if the respiratory support is deemed ineffective or if the neonate is deemed compromised at any time by the clinician the umbilical cord will be clamped and standard resuscitation as per ANZCOR guidelines will be provided. Heart rate will be monitored by auscultation, pulse oximetry or ECG leads, which is the standard of care at Monash Health in preterm neonates.
The intervention will be provided by a member of the research team (medical doctor) or by a member of the clinical team who has been trained in the intervention while being supervised by a member of the research team.
A member of the research team will be present during the intervention to ensure the intervention is being adhered to.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To assess the feasibility of providing nasal non-invasive ventilation during delayed cord clamping to neonates born <32 weeks.

Timepoint [1]

At time of intervention

Secondary outcome [1]

Duration of delayed cord clamping

Timepoint [1]

At the time of umbilical cord clamping after birth.

Secondary outcome [2]

APGAR scores

Timepoint [2]

1, 5 and 10 minutes of life.

Secondary outcome [3]

Oxygen saturations during resuscitation.

Timepoint [3]

This will be measured at 60 seconds and every 60 seconds thereafter until the end of the resuscitation.

Secondary outcome [4]

Surfactant administration and method of administration.

Timepoint [4]

Any time point within 72 hours after birth

Secondary outcome [5]

Grade of Intraventricular Hemorrhage

Timepoint [5]

Routine screening cranial ultrasound in keeping with local guidelines. For all infants born less then 32 weeks gestations, Cranial ultrasound will be undertaken on day 8, 14, 28, 42 (+/- 1 day). For those born less than 28 gestation an additional cranial ultrasound will be undertaken at day 3 of life (+/- 1 day). This will be assessed by audit of electronic medical records.

Secondary outcome [6]

Rates of chronic lung disease

Timepoint [6]

36 weeks corrected gestational age.

Secondary outcome [7]

Corrected gestational age of the infant successfully weaning off any respiratory support (supplemental oxygen and/or CPAP/HiFlow).

Timepoint [7]

Follow up until discharge home.

Secondary outcome [8]

Adverse events prior to hospital discharge

Timepoint [8]

During hospital stay

Secondary outcome [9]

Heart rate

Timepoint [9]

This will be measured at 60 seconds and every 60 seconds thereafter until the end of the resuscitation.

Secondary outcome [10]

Intubation and mechanical ventilation within the first 72 hours after birth.

Timepoint [10]

Within 72 hours after birth.

Eligibility

Key inclusion criteria

Babies born between 24+0 and 31+6 weeks’ gestation born at Monash Medical Centre (MMC) Clayton.

Minimum age

0 Hours

Maximum age

0 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Neonates will be excluded if they have a known congenital abnormality that significantly affects the cardiorespiratory system, i.e. congenital diaphragmatic hernia or cyanotic congenital heart defect.

Neonates that are planned to receive comfort care only, i.e. not to receive resuscitation or initiation of intensive care, will be excluded.

Study design

Purpose of the study

Treatment

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/08/2025

Actual

Date of last participant enrolment

Anticipated

30/11/2026

Actual

Date of last data collection

Anticipated

30/06/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC grant

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr. Doug Blank, Monash Health, Monash University, VIC

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr. David Mc Hugh, Monash Health, Monash University, VIC

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro North Health Human Research Ethics Committee A

Ethics committee address [1]

https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/09/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Infants born very preterm have a high mortality rate and are at increased risk of worse neurodevelopmental outcomes and health-related problems. In recent years, convincing evidence has led to improved care and novel interventions for stabilisation of the newborn in the first 10 minutes of life, which may have a long-lasting impact on neonatal outcome.
Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. ) After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases.  CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. 
 	While the rationale of most cord clamping studies has previously been based on the effects of placental transfusion, more recent studies in preterm lambs have demonstrated that delaying cord clamping until after ventilation onset prevents a rapid decrease in cardiac output. The observed large fluctuations in systemic and cerebral haemodynamics, and concomitant bradycardia and hypoxia frequently observed in preterm infants after ICC, could be avoided by delaying cord clamping until after aeration of the lung
When a baby stops breathing or fails to establish normal breathing pattern positive pressure ventilation via a face mask is commenced to provide respiratory support while transitioning. The clinician attempts to create an air-tight seal on the infant’s face, with the nose and mouth inside the internal diameter of the mask. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring.
Studies have shown that the majority of VPTI born less than 32 weeks completed gestation have a good respiratory drive immediately after birth. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. 
In this feasibility study we will recruit 40 very preterm neonates born from 24+0 weeks to 31+6 weeks completed gestation. We will provide nasal respiratory support to the participants at birth prior to umbilical cord clamping. We will provide CPAP (Continuous positive airway pressure) and if they baby is not spontaneously breathing will provide non-invasive ventilation to the baby. The aim of this study is to enable a longer period of delayed umbilical cord clamping (DCC) and improve cardiopulmonary transition in the neonates.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Doug Blank

Address

Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia

Country

Australia

Phone

+61 3 8572 3600

Fax

[email protected]

Contact person for public queries

Name

Dr. David Mc Hugh

Address

Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia

Country

Australia

Phone

+61 3 8572 3600

Fax

[email protected]

Contact person for scientific queries

Name

Dr David Mc Hugh

Address

Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia

Country

Australia

Phone

+61 3 8572 3600

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: No, there is no plan for an IPD. There is no other similar trial currently running. We do not anticipate an IPD meta-analysis in the future.

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.

Trial Review

Documents added manually

Documents added automatically