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Provision of breathing support during delayed cord clamping in preterm infants.

In preterm infants <31 weeks receiving delayed cord clamping (DCC) at birth but who do not concurrently establish spontaneous ventilation, does breathing support during DCC versus no breathing support during DCC effect the volume of placental transfusion and cardiovascular stabilisation.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001026516
Acronym
The ABC Study: 'Assisted breathing before cord clamping"
Enrollment
120
Registered
2015-10-01
Start date
2016-03-17
Completion date
2020-09-15
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The amount of placental transfusion (PLT) preterm infants receive at birth with the umbilical cord intact has been shown to have important effects on the transitional circulation in the first 24-48hrs of life. Not only does PLT effect the requirement for red blood cell (RBC) transfusions in the neonatal period but also alters important long-term neonatal outcomes such as intraventricular haemorrhage (IVH) and chronic lung disease (CLD). Observational work from Middlemore Neonatal Unit demonstrated that preterm infants that breathe during delayed cord clamping(DCC) receive a larger PLT and have significantly less CLD and less severe (grade 4) IVH than infants that did not breathe during the procedure. Similarly, a study in term infants showed lower mortality in infants that breathed during DCC. A preterm animal model showed improved cerebral circulation during transition in lambs that were ventilated during DCC. These studies suggest that establishing respiration during DCC could protect the most vulnerable preterm infants from the under perfusion-reperfusion cycle which leads to IVH. In addition, because respiration during DCC enhances PLT it is hypothesised that the requirement for blood transfusion will be reduced. Therefore, important health benefits and reduced costs together with improved long term outcomes could result and positively impact on the quality of life for the prematurely born infant and their families.

Interventions

In addition to standard treatment, breathing support in the form of positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) delivered by mask and pressure controlled device. Infants will be randomised at 15 sec of age once their breathing has been assessed. Breathing support will begin at 20sec of age, will be continued for a duration of 30sec; the intervention will take place while 50 sec DCC is occuring (cord clamping to take place at 50sec of age). ILCOR and NZ resu

In addition to standard treatment, breathing support in the form of positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) delivered by mask and pressure controlled device. Infants will be randomised at 15 sec of age once their breathing has been assessed. Breathing support will begin at 20sec of age, will be continued for a duration of 30sec; the intervention will take place while 50 sec DCC is occuring (cord clamping to take place at 50sec of age). ILCOR and NZ resuscitation guidelines will be adhered to (initial positive pressure will be 20-25 cm water and CPAP 5-8cm water). The intervention received will be recorded on a data capture sheet including PPV time period in seconds received and or CPAP time period in seconds.

Sponsors

Middlemore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

Infants born <31 week gestation and undergoing delayed cord clamping (DCC); born by vaginal or caeserean section and deemed not to have regular rhythmic breathing (chest wall movement) after 15sec of DCC.

Exclusion criteria

Infants born equal or > 31 week gestation, known congenital abnormality, twin-to-twin transfusion syndrome, severe antenatal intrauterine growth restriction (estimated fetal weight <10th customised centile), placental abruption, delivery of placenta and infant simultaneously (en caul), short umbilical cord, obsterician refusal, declined antenatal consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026