Actively Recruiting

Phase Not Applicable
Age: 0 - 30Minutes
All Genders
NCT06557551

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

Led by University College Dublin · Updated on 2024-10-15

164

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0 - 30Minutes
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants of any sex born before 28 weeks of gestation
  • Clinicians plan to provide intensive care
  • Consent for their participation provided by parent(s)/guardian(s) before their birth
Not Eligible

You will not qualify if you...

  • Major congenital anomalies such as upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, or cardiac lesions other than ASD/PFO/VSD/PDA

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Maternity Hospital

Dublin, None Selected, Ireland, D02 YH21

Actively Recruiting

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Research Team

C

Colm PF O'Donnell, MB PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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