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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from King's College Hospital NHS Trust

Record History

  1. Notable Primary and study completion pushed from Sep 2026 to Sep 2027
    • Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to May 8, 2024
    v3
  2. Minor Secondary endpoints: details revised at 6 of 8 entriesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 treatment, compared to when they don't receive this treatment. The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
Trial Details
NCT Number NCT06421506
Lead Sponsor King's College Hospital NHS Trust
Collaborators: Chiesi Limited
Conditions
(from sponsor)
Respiratory Distress Syndrome, Preterm Pregnancy, Surfactant Deficiency Syndrome Neonatal
Related terms Pulmonary Atelectasis, Respiratory Distress Syndrome
Enrollment 245 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov