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Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants

RecruitingNAAges 34 Weeks - 38 WeeksAllKing's College Hospital NHS Trust
NCT06421506 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early. Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in. High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose. The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatme

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support. * Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support. Exclusion Criteria: * Infants requiring intubation at birth * Infants with severe congenital anomalies.
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What it tests

  • Less invasive surfactant administration during high flow nasal cannula treatment
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Where

1 site
King's College Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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