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deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants

RecruitingNAAges 24 Weeks - 32 WeeksAllMurdoch Childrens Research Institute
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In plain words

What the trial is, and whether it could suit you

Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy. Surfactant replacement therapy is an established therapy for the treatment of respiratory distress syndrome, which is a common illness in infants born preterm. Surfactant replacement therapy can be delivered to an infant's lungs a few ways, including via a small tube that is briefly placed down an infant's throat. This is considered the least invasive method currently available, and is becoming more popular. It is referred to as minimally invasive surfactant therapy (MIST). A baby can receive surfactant via MIST if they are receiving non-invasive respiratory support, like from a continuous positive airway pressure (CPAP) machine. Doctors and resear

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Born between 24 to 31+6 weeks' gestation, by best obstetric estimate * Admitted to a participating NICU * A parent/guardian who can provide informed consent * Receiving CPAP respiratory support * Planned to receive MIST by clinicians as standard clinical care * Clinically stable (as determined by clinical team) * Infant less than 72 hours of age * MIST can be administered within 90 min of allocating assigned interventional arm Exclusion Criteria: * Receiving any form of respiratory support other than CPAP * Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth) * The infant's clinical team has concern regarding clinical stability and tolerability of EIT * The infant's skin integrity will not tolerate the EIT belt and gel * Refusal of informed consent by their parent/guardian/legally acceptable representative * The infant does not have a parent/guardian who can provide informed consent. * Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes * Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early post-natal life * Suspected or confirmed air leak or pneumothorax * Previous treatment with surfactant or mechanical ventilation via an endotracheal tube * Urgent need for intubation and mechanical ventilation as determined by the treating clinician * Not receiving full active intensive care (i.e. palliative/comfort care)
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What it tests

  • Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy
  • Control (Minimally Invasive Surfactant Therapy)
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Where

1 site
Joan Kirner Women's and Children's Hospital
Saint Albans, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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