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

NCT06421506 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome
  • Preterm Pregnancy
  • Surfactant Deficiency Syndrome Neonatal

Interventions

PROCEDURE

Less invasive surfactant administration during high flow nasal cannula treatment

Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.

Sponsors & Collaborators

  • Chiesi Limited

    collaborator UNKNOWN

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Theodore Dassios, PHD · King's College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
38 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-09-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421506 on ClinicalTrials.gov