RecruitingACTRN12625000790448

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

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


Sponsor

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

Enrollment

40 participants

Start Date

Dec 25, 2025

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 0 Hourss

Plain Language Summary

Simplified for easier understanding

Very premature babies — born before 32 weeks — face significant challenges in the moments immediately after birth as they transition from relying on the placenta to breathing air on their own. Delaying the cutting of the umbilical cord (called deferred cord clamping) after birth allows blood to continue flowing from the placenta to the baby, which has been shown to improve outcomes. But most resuscitation and breathing support currently has to be given after the cord is cut. This feasibility study is testing whether it is possible to provide nasal breathing support (CPAP or gentle non-invasive ventilation) to very preterm babies while the umbilical cord is still attached — potentially allowing a longer period of cord clamping and a smoother transition to independent breathing. The study is recruiting 40 premature babies born between 24 and 31 weeks at Monash Medical Centre. Your baby may be eligible if they are born between 24 and 31 weeks gestation at Monash Medical Centre. Babies with known major heart or lung abnormalities or those receiving comfort care only would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 o

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.


Locations(1)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12625000790448


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