P07
Conditions
Interventions
Group 1: Infants will be randomized immediately before birth. After placement of the infant on a resuscitation bed, all infants will receive a positive end-expiratory pressure (PEEP
+/- noninvasive positive pressure ventilation - NIPPV), as recommended in resuscitation guidelines.
The intervention and control groups will receive different PEEP levels for the first ten minutes aft
Sponsors
LMU Klinikum
Universitätsspital Zürich, Klinik für Neonatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: None
Exclusion criteria
Exclusion criteria: - Directed towards palliative care a priori - Not born at the recruiting center (outborn) - Severe congenital malformation, which is adversely affecting initial respiratory management after birth, known prior to birth - No informed consent provided by the parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the DOOR outcome at 44 weeks post-menstrual age or at discharge home, whichever comes first. Desirability of Outcomes Ranking (DOOR) approach: The ranking reflects their relative importance to affected families: Rank 6Death Rank 5Alive with both of the following major morbidities: moderate/severe BPD and severe brain lesion (IVH = III°, cPVL, any ventricular shunt/reservoir (e.g. ventriculoperitoneal shunt, ventricular reservoir for puncture), any cerebellar hemorrhage) Rank 4Alive with one of the major morbidities (list see above) Rank 3Alive without major morbidities but with any of the following moderate morbidities: Sum of hours of invasive mechanical ventilation = 72 hours within the first seven days or IVH I/II° or pneumothorax requiring drainage Rank 2Alive without major or moderate morbidities (see above) but with: Respiratory failure within the first 72 hours after birth (definition see below) Rank 1Alive and well (none of the above) Infants will be ranked according to their respective outcomes. In case two or more infants receive the same DOOR rank, the overall duration of respiratory support (i.e. duration of invasive + any non-invasive ventilation, including low-flow oxygen support) will be used as so-called “tie-breaker” for ranks 1-5 (Response Adjusted for Duration of respIratOry support, RADIO; i.e. DOOR/RADIO-approach) with a shorter duration of respiratory support being assigned a better rank. For rank 6 (mortality), infants with a longer duration of respiratory support (and thus, a longer time alive) will receive the better rank. NB: Respiratory failure is defined as meeting any of the following criteria in the first 72 hours after birth: -a fraction of inspired oxygen of 0.3 or higher for more than one hour to maintain oxygen saturations in unit-specific target ranges -a pH of 7.2 or less plus a partial pressure of carbon dioxide greater than 60 mmHg (8.0 kPa) in two subsequent samples of arterial or capillary blood, collect | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality, any severe brain lesion, severe IVH, any IVH, cystic PVL, need for ventricular shunt/reservoir, cerebellar hemorrhage, moderate/severe BPD, pneumothorax requiring drainage, need for invasive mechanical ventilation, respiratory failure within the first 72 hours after birth, overall duration of respiratory support, need for escalation of respiratory support in the delivery room | — |
Countries
Australia, Germany, Switzerland
Contacts
Public ContactVincent Gaertner
LMU Klinikum, Abteilung für Neonatologie
Outcome results
None listed