Influence of CPAP versus high-flow nasal cannula on oxygenation and ventilation parameters in preterm infants after respiratory distress syndrome - a randomised clinical trial

Not Applicable

Recruiting

• Conditions: P28.4; Other apnoea of newborn

• Registration Number: DRKS00031934
• Lead Sponsor: niversitätsklinikum Gießen, Abteilung Allgemeine Pädiatrie und Neonatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Premature infants (birth weight < 1.500 g) treated in the neonatal intensive care unit or the intermediate care unit
2. FiO2 under CPAP/NIPPV < 0.3 with PEEP = 5 mmHg
3. Need of non-invasive ventilation (CPAP/NIPPV)
4. At least 4 hypoxaemias (< 80% SpO2) or 4 apnoeas/bradycardias in 8 hours before study entry
5. Less than > 2 irritable/intervention events/4h (defined as SpO2 < 80% for > 1 min or heart rate < 100/min for > 30 seconds) before study entry
6. Written informed consent from the legal guardians has been obtained

Exclusion Criteria

1. Premature and newborn infants with severe malformations that significantly affect respiratory regulation (severe CNS malformations), pulmonary function (e.g. pulmonary hypoplasia, acute extraalveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or circulatory function (congenital cynaotic cardiac disease, severe septic shock)
2. Postnatal age < 120 h (often acute deterioration in the early phase of respiratory distress syndrome and to protect the minimal handling principle in the critical phase to prevent intraventricular hemorrhage)
3. Clinical sepsis (defined as CRP > 10 mg/l) with or without circulatory insufficiency or positive blood culture
4. FiO2 under CPAP/NIPPV > 0.3 with PEEP > 5 mmHg
5. Significant apnoea-bradycardia-syndrome (> 2 irritable/intervention events/4h = SpO2 < 80% for > 1 min or heart rate < 100/min for > 30 seconds) before study entry
6. Anticipatory blood transfusion during the study phase

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute time in percent (%) preterm infants spent within the specific oxygen saturation target range (88-95%).