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Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial

NCT06557551 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-10-15

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.

The main question it aims to answer is:

Do fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?

Extremely premature babies who are receiving breathing support through a face mask will either:

* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or
* Continue on face mask breathing support.

All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.

Conditions

  • Infant, Newborn, Diseases
  • Prematurity
  • Prematurity; Extreme
  • Respiratory Distress Syndrome in Premature Infant

Interventions

OTHER

Thin catheter surfactant

Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life

Sponsors & Collaborators

  • University College Dublin

    lead OTHER

Principal Investigators

  • Colm PF O'Donnell · National Maternity Hospital, University College Dublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2026-11-30
Completion
2027-02-28

Countries

  • Ireland

Study Locations

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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 NCT06557551 on ClinicalTrials.gov