Positive end-expiratory pressure levels during resuscitation of preterm infants at birth

Phase 3

Conditions: aeration of preterm lungs
Preterm transition
10028971

Registration Number: NL-OMON50778

Lead Sponsor: Murdoch Children's Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

- infant born between 23 weeks 0 days and 28 weeks 6 days PMA
- planned to receive respiratory support intervention (resuscitation) at birth
with nCPAP and or positive pressure ventilation in the delivery room to support
transition and/or respiratory failure related to pretermaturity
- the infants has a parent or other legal representative capable of
understanding the informed consent document and providing consent on the
participants behalf either orospectively or after birth and randomsation if
prenatal consent was not possible

Exclusion Criteria

- infants is not planned fot active care (based on the attending clinician or
by family decision)
- infant with potential severe pulmonary hypoplasia due to PPROM or hydrops
foetalis
- major congenital anomaly's
- refused informed consent
- no guardian who can provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>The primary objective of this study is to evaluate the impact of dynamic PEEP<br /><br>on the incidence of survival without BPD in extremely preterm infants born <29<br /><br>weeks PMA compared with static PEEP.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of this study are to compare the rates of common<br /><br>neonatal morbidities. We will capture many of the same initial DR resuscitation<br /><br>details, short-term respiratory morbidity, and potential harm secondary<br /><br>outcomes as the SAIL Trial[33], plus the additional secondary outcomes specific<br /><br>to applied positive pressures in the DR and NICU as detailed in Section 10.2.<br /><br>In particular, the principal secondary outcomes of:<br /><br>* Failure of non-invasive ventilation in first 72 hours (treatment failure)<br /><br>* Oxygen requirement >=50% for 3 or more consecutive hours in first 72 hours<br /><br>* Surfactant therapy in the first 7 days<br /><br>* Air leak and/or pulmonary interstitial emphysema (defined on chest<br /><br>radiograph; CXR) in the first 10 days of life<br /><br>* Patent ductus arteriosus requiring therapy in the first 72 hours<br /><br>* Imaging findings of intraventricular haemorrhage (grade III-IV)</p><br>