A pilot study on delivery suite mask ventilation in extremely preterm infants

Not Applicable

Recruiting

• Conditions: eonatal resuscitation; Extremely preterm infants; Neonatal resuscitation; Reproductive Health and Childbirth - Complications of newborn; Public Health - Health service research; Respiratory - Normal development and function of the respiratory system

• Registration Number: ACTRN12614000245695
• Lead Sponsor: eonatal Intensive Care Unit, Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Preterm infants at <30 weeks gestation requiring respiratory support in delivery suite

Exclusion Criteria

Lethal congenital anomalies
Upper airway anomalies
Unavailability of the research team

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mask leak : Percentage mask leak is defined as (tidal volume inspired - tidal volume expired) / Tidal volume inspired x 100. This would be calculated by the NM3 respiratory function monitor.[At resuscitation];Airways obstruction : Airways obstruction will be defined as a 75% reduction in expired tidal volume compared to the baseline of 10 inflations prior the obstructed inflation. This would be demonstrated on the NM3 respiratory funciton monitor.[At resuscitation];Need for endotracheal intubation, which will be evaluated from patient's medical records[Endotracheal intubation in delivery suite]

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation, which will be assessed by reviewing the patient's medical records[The secondary outcome will be assessed at discharge from the Neonatal Intensive Care Unit];Duration of hospital stay[Duration of hospital stay will be assessed at discharge from neonatal nursery and will be recorded from patient's medical records];Chronic lung disease, which is defined as need for supplemental oxygen and/or respiratory support at 36 weeks corrected gestational age[36 weeks corrected gestational age];Intraventricular hemorrhage, will be defined according to the papile classification (Grade I to grade IV) assessed routinely within 7 days and at 6 weeks of age[6 weeks of life]