N/A
N=62
Mask Ventilation With Different Face Masks During Neonatal Resuscitation
Respiration; Insufficient or Poor, Newborn
Bottom Line
View on ClinicalTrials.gov: NCT01685697 ↗Enrolled (actual)
62
Serious AEs
7.1%
Results posted
Nov 2018
Primary outcome: Primary: Difference in Percentage of Leak — 35; 30 % (percentage of mass leak)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mask ventilation with a Laerdal face mask (Procedure); Mask ventilation with a F&P face mask (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Percentage of Leak |
35; 30 | — |
Summary
Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.
To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher & Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital.
The purpose of this study is to find out if one facemask is leaking less between the face and the mask.
Eligibility Criteria
Inclusion Criteria
- Preterm infants <32 weeks gestation born at The Royal Alexandra Hospital who require resuscitation in the delivery room will be recorded.
Exclusion Criteria
- Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.
Participants will be included in the first minutes after birth if they require mask ventilation for poor respiratory effort. Data will be collected from the Hospital chart until discharge at around 40 weeks gestation.
Data sourced from ClinicalTrials.gov (NCT01685697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.