NCT06421506 Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
| NCT ID | NCT06421506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College Hospital NHS Trust |
| Condition | Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 245 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 245 participants in total. It began in 2024-05-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Theodore Dassios, PHD
PRINCIPAL INVESTIGATOR
King's College London
Frequently Asked Questions
Who can join the NCT06421506 clinical trial?
This trial is open to participants of all sexes, aged 34 Weeks or older, up to 38 Weeks, studying Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06421506 currently recruiting?
Yes, NCT06421506 is actively recruiting participants. Contact the research team at eleanor.jeffreys@nhs.net for enrollment information.
Where is the NCT06421506 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06421506 clinical trial?
NCT06421506 is sponsored by King's College Hospital NHS Trust. The principal investigator is Theodore Dassios, PHD at King's College London. The trial plans to enroll 245 participants.