RecruitingACTRN12609000986279

A randomized controlled trial of modes of ventilatory support in preterm babies from point of delivery to the neonatal intensive care unit.

In preterm babies born at the Nepean Hospital less than 30 weeks’ gestational age and requiring ventilation in the delivery suite, would the use of volume-targeted ventilation as compared to standard intermittent mandatory ventilation from the point of delivery until admission to the neonatal intensive care unit reduce the incidence of hypocarbia in the first 2 days of life?

Sponsor

Dr Mark Tracy

Enrollment

90 participants

Start Date

Nov 29, 2006

Study Type

Interventional

Conditions

Blood oxygen level on admission to the NICU Oxygen saturation and blood delivery to the brain, as measured by Near Infra-Red Spectroscopy (NIRS)Blood carbon dioxide on admission to the Neonatal Intensive Care Unit (NICU)Development of intra-ventricular haemorrhage and/or periventricular leukomalacia Presence or absence of cerebral autoregulation as determined by NIRS and its relationship to hypocarbia on arrival in the NICU

Summary

Most newborn infants less than 30 weeks' gestational age at birth require either nasal continuous positive airway pressure (nCPAP) or intubation and mechanical ventilation for acute respiratory distress syndrome at the point of delivery, whether in the delivery suite or in the operating theatre. This is an interventional study looking at whether using a targeted expiratory tidal volume mode of ventilation from the point of delivery until admission in the neonatal intensive care unit may improve a newborn infant's blood gas parameters on arrival in the neonatal intensive care unit. Monitoring and adjusting ventilation to achieve normal arterial carbon dioxide levels is standard practice once the baby is within the neonatal intensive care unit. Current best practice recommends using handbagging ventilation or intermittent mandatory ventilation (IMV); volumes of each breath are not usually measured until the newborn is connected to a ventilator in the neonatal intensive vare unit . The use of an advanced neonatal ventilator which can target set expiratory tidal volumes in the resuscitation, stabilisation and transport of such a premature neonate may allow better arterial blood gases on arrival to the neonatal intensive care unit. Further, the impact of the use of an advanced neonatal ventilator from point of delivery may influence the initial respiratory course as well as the cerebrovascular circulation. This randomised controlled trial (RCT) may demonstrate the value of using an advanced neonatal ventilator in the initial ventilatory management of critically ill newborn babies.

Eligibility

Sex: Both males and femalesMin Age: 23 WeekssMax Age: 29 Weekss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using an advanced breathing machine (ventilator) that targets a specific amount of air with each breath from the moment of birth can lead to better blood oxygen and carbon dioxide levels when very premature babies arrive in the neonatal intensive care unit (NICU). Babies born before 30 weeks of pregnancy are often too small and underdeveloped to breathe on their own and need breathing support right from delivery. The study compares standard manual breathing support to advanced ventilator-controlled support during the journey from delivery room to NICU. You may be eligible if: - Your baby is born at less than 30 weeks of pregnancy (gestation) You may NOT be eligible if: - There is a suspected underdevelopment of the baby's lungs (pulmonary hypoplasia) - There is a suspected chromosomal abnormality - There is a suspected genetic syndrome Talk to your doctor about whether this trial might be right for you.

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

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Interventions

Triggered, volume-targeted mechanical ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit. Ventilator set to target an exhaled tidal

Triggered, volume-targeted mechanical ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit. Ventilator set to target an exhaled tidal volume of 5 mL/kg with inspiratory pressures automatically adjusted breath-to-breath by the ventilator depending on pulmonary compliance. Cerebral oxygenation monitoring using spatially resolved near infra-red spectroscopy in the first 48 hours of life; ultrasound assessment of cardiac output and presence of a patent ductus arteriosus in the first 48 hours of life.

Locations(1)

Australia

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ACTRN12609000986279