Clinical trial Recruiting at 1 site Interventional Ages Any age to 30 Minutes

Giving surfactant to premature infants using a thin catheter at birth

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

Run by University College Dublin · NCT06557551 · Data updated 2026-11-12

This study is testing if giving a special lung treatment to very premature babies right after birth using a thin tube can help them breathe better and need less breathing support in their first few days of life.

More Infant, Newborn, Diseases trials

Quick facts

Study typeInterventional
AgesAny age to 30 Minutes
SexAll
Enrollment164 (estimated)
SponsorUniversity College Dublin
Academic / other
Locations1 site (Dublin, None Selected)
StatusRecruiting
StartedAugust 19, 2024
Main results expectedNovember 30, 2026
Study endsFebruary 28, 2027
Registry record updatedOctober 15, 2024
Trial IDNCT06557551 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants born before 28 weeks of gestation who require intensive care.

Probably not a fit

Patients with major congenital anomalies or those not requiring intensive care may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if administering surfactant through a thin endotracheal catheter to extremely premature infants shortly after birth can reduce the need for mechanical ventilation within the first 72 hours of life. Infants born before 28 weeks of gestation who are receiving breathing support will be randomly assigned to receive surfactant via a thin catheter or continue with face mask support. The study will closely monitor the infants to assess the impact of this method on their respiratory outcomes.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of mechanical ventilation and improve respiratory outcomes for extremely premature infants.

How similar studies have gone: Previous studies have shown that less-invasive surfactant application is associated with improved outcomes compared to traditional methods, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria

* 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

Exclusion criteria

• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD/PFO/VSD/PDA )

Where it's running

  • National Maternity Hospital
    Dublin, None Selected, Ireland
    Recruiting

Study contacts

  • Principal investigator: Colm PF O'Donnell — National Maternity Hospital, University College Dublin
  • Study coordinator: Colm PF O'Donnell, MB PhD
  • Email: codonnell@nmh.ie
  • Phone: 35316373100

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.