None listed
Conditions
Brief summary
This multicentre randomised controlled trial will determine how best to apply Positive End-Expiratory Pressure (PEEP) to support the preterm lung during stabilisation (‘resuscitation’) at birth. PEEP is a proven therapy that helps preterm babies breath but what PEEP levels to use is unknown. Currently PEEP levels of 5-6 cmH2O are usually used, but increasing evidence suggests that higher PEEP levels than this are initially needed immediately after birth. We hypothesise that in preterm infants born between 23 and 28 weeks post menstrual age, a high, dynamic PEEP strategy (PEEP 8-10 cmH2O individualised to clinical need) as compared to a standard, static PEEP of 5-6 cmH2O during stabilisation at birth, will 1) increase survival without bronchopulmonary dysplasia, 2) reduce the failure of non-invasive respiratory support in the first 72 hours of life (co-primary outcomes), and 3) reduce rates of common neonatal morbidities (secondary outcomes).
Interventions
High dynamic Positive End-expiratory Pressure (PEEP): Initial PEEP delivered at 8 cmH2O via a T-Piece resuscitator in an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). Increase in PEEP to 10 cmH2O (2 cmH2O increment) at 60s if infant meets pre-defined criteria for respiratory deterioration (see below). Ongoing resuscitative care at PEEP 10 cmH2O unless the infant has a heart rate >120 bpm and oxygen needs <0.30 for
High dynamic Positive End-expiratory Pressure (PEEP): Initial PEEP delivered at 8 cmH2O via a T-Piece resuscitator in an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). Increase in PEEP to 10 cmH2O (2 cmH2O increment) at 60s if infant meets pre-defined criteria for respiratory deterioration (see below). Ongoing resuscitative care at PEEP 10 cmH2O unless the infant has a heart rate >120 bpm and oxygen needs <0.30 for more than 60s in which case PEEP will be reduced to 8 cmH2O. Respiratory Deterioration is defined as a heart rate <100 beats per minute (bpm), apnoea, and/or increasing oxygen required to maintain heart rate and SpO2 targets, these criteria indicating that additional resuscitation measures need to be implemented.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Each infant must meet all of the following criteria to be enrolled in this study: 1. Born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate) 2. Receives respiratory intervention (resuscitation) at birth with CPAP and/or positive pressure ventilation in the DR to support transition and/or respiratory failure related to prematurity 3. Has a parent or other legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf either prospectively or after birth and randomisation if prenatal consent was not possible (at sites where the Ethics Committee permits waiver of prospective consent).
Exclusion criteria
Infants meeting any of the following criteria will be excluded from the study: 1. Not for active care based on assessment of the attending clinician or family decision 2. Anticipated severe pulmonary hypoplasia due to rupture of membranes <22 weeks’ with anhydramnios or fetal hydrops 3. Major congenital anomaly or anticipated alternative cause for respiratory failure 4. Refusal of informed consent by their legally acceptable representative 5. Does not have a guardian who can provide informed consent.
Outcome results
None listed