Anatomical versus round facemasks for breathing support in newborns
Official title: NeoSHARK: Neonatal Study of Two-Handed Anatomical Versus Round facemasK Ventilation in Preterm and Term Infants; a Randomised Controlled Trial
Run by University College Dublin · NCT07524517 · Data updated 2026-11-12
We will test whether an anatomical (triangular) facemask or a round facemask, both held with a two-handed grip, reduces air leak when giving breaths to preterm and term newborns who need mask ventilation before intubation.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin, Leinster) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | January 2027 |
| Study ends | February 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07524517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm and term neonates in the neonatal unit who require mask ventilation prior to an attempted intubation and for whom the clinical team plans mask ventilation are eligible.
✕Probably not a fit
Infants with congenital facial malformations that affect mask seal, or babies who do not require mask ventilation prior to intubation, are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Facemask leak and airway obstruction are common during neonatal mask ventilation and can result in ineffective support for babies. This single-center interventional study will compare measured mask leak when healthcare professionals use either an anatomical facemask or a round facemask, both applied with a two-handed hold, during mask ventilation before intubation. The primary outcome is the amount of air leak recorded during ventilation. The goal is to determine whether one mask shape combined with a two-handed technique gives more effective mask seal in clinical neonatal care.
Why it matters
Potential benefit: If successful, the findings could reduce mask leak during neonatal ventilation and improve the effectiveness and safety of immediate breathing support for newborns.
How similar studies have gone: Previous manikin studies showed no consistent difference between mask shapes with a one-handed hold, while recent benchtop and some clinical data suggest a two-handed hold reduces leak for round masks, but the combination of an anatomical mask with a two-handed hold has not yet been tested clinically.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication, and who require mask ventilation prior to intubation attempt. Exclusion Criteria: * Neonates with a congenital malformation that would impact mask seal will not be included.
Where it's running
-
The National Maternity Hospital Dublin
Dublin, Leinster, Ireland Recruiting
Study contacts
- Study coordinator: Laura J Ryan
- Email: laura.ryan5@gmail.com
- Phone: +353851551609
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.