Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome.
Mohamed E Abdel-Latif, Peter G Davis, Kevin I Wheeler...
https://pubmed.ncbi.nlm.nih.gov/33970483Actively Recruiting
Phase Not Applicable
Age: 0 - 30Minutes
All Genders
ID06557551
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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether giving surfactant through a thin endotracheal catheter to extremely premature babies right after birth can reduce the need for mechanical ventilation in the first three days of life. The trial focuses on infants born before 28 weeks of gestation who are at risk of respiratory distress syndrome and usually receive breathing support with continuous positive airway pressure (CPAP). The study compares this new less-invasive surfactant method under video laryngoscopy guidance to standard face mask breathing support without surfactant. In the intervention group, at or after 5 minutes of life, a thin catheter is inserted into the baby's windpipe using video laryngoscopy to deliver surfactant, then immediately removed so the baby continues with face mask breathing support. The control group continues with face mask breathing support only. The surfactant doses vary by gestational age, and video laryngoscopy helps ensure correct catheter placement. This trial aims to see if early surfactant given this way reduces the need for ventilation and related complications. Participants are closely monitored for whether they require intubation and mechanical ventilation within the first 72 hours of life. Additional measures include the success of catheter insertion, heart rate changes, respiratory support needed, and various health outcomes up to four months or hospital discharge. The study tracks complications like bronchopulmonary dysplasia, brain hemorrhages, and other serious conditions. Overall, the trial evaluates whether this new surfactant delivery method improves breathing support outcomes in extremely premature infants.
CONDITIONS
Brief 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
You may qualify if you...
- Infants of any sex born before 28 weeks of gestation
- Clinicians plan to provide intensive care
- Consent for participation is provided by parent(s)/guardian(s) before birth
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 significant cardiac lesions other than ASD, PFO, VSD, or PDA
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Shortly after birth
Participants receive surfactant through a thin endotracheal catheter inserted under video laryngoscopy shortly after birth, or continue with face mask breathing support according to their assigned group.
1 procedure at or after 5 minutes of life
Follow-up
Duration - Up to 4 months or until hospital discharge, whichever occurs first
Participants are monitored during their hospital stay for respiratory support, complications, and other health outcomes until discharge or up to 4 months of age.
Ongoing assessments during hospitalisation
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
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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Published Research Related To This Trial
Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants.
Lucy E Geraghty, Emma A Dunne, Caitríona M Ní Chathasaigh...
https://pubmed.ncbi.nlm.nih.gov/38709215Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome.
Felicia L Bahadue, Roger Soll
https://pubmed.ncbi.nlm.nih.gov/23152207