A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Locations
- 6
- Primary Endpoint
- Delivery room intubation or death
Study Overview
Brief Summary
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?
Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born <28 weeks.
Detailed Description
The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.
The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.
During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.
Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.
After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Born <28 weeks gestational age at a university hospital
- •Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given
Exclusion Criteria
- •Decision on treatment limitations before randomisation
- •Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
- •Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
- •Known neuromuscular disease
- •No study neonatologist available
Arms & Interventions
Investigational Device: The New System
Intervention: New system used for respiratory support (Device)
Reference Device: T-piece System
Intervention: T-piece used for respiratory support (several manufacturers) (Device)
Outcomes
Primary Outcomes
Delivery room intubation or death
Time Frame: 0-30 minutes
The primary outcome is delivery room intubation or death. Death has to be included in the primary outcome since patients that die may not always be intubated. The variable is a dichotomous outcome and reported by the resuscitation team.
Secondary Outcomes
- Failed ventilation(0-30 minutes)
- Device problems or malfunction(0-30 minutes)
- Time to primary outcome (intubation or death)(up to 72 hours of age)
- Death(up to 72 hours of age)
- Intra ventricular haemorrhage grade III or more(up to 72 hours of age)
- Airleaks and pneumothorax(up to 72 hours of age)
Investigators
Baldvin Jonsson
Associate Professor and Clinical Director Karolinska University HospitalKarolinska University Hospital
Karolinska Institutet