Giving surfactant to premature infants using a thin catheter at birth
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
NA · University College Dublin · NCT06557551
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | N/A to 30 Minutes |
| Sex | All |
| Sponsor | University College Dublin (other) |
| Locations | 1 site (Dublin, None Selected) |
| Trial ID | NCT06557551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 28 weeks of gestation who require intensive care.
Not a fit: Patients with major congenital anomalies or those not requiring intensive care may not benefit from this study.
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 performed: Previous studies have shown that less-invasive surfactant application is associated with improved outcomes compared to traditional methods, indicating a promising approach.
Eligibility criteria
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 this trial is running
Dublin, None Selected
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant, Newborn, Diseases, Prematurity, Extreme, Respiratory Distress Syndrome in Premature Infant