Influence of non-invasive positive pressure ventilation versus nasal high-frequency oscillation ventilation on parameters of oxygenation and ventilation in premature infants in the weaning phase after respiratory distress syndrome

• Conditions: P22.0; Respiratory distress syndrome of newborn

• Registration Number: DRKS00023438
• Lead Sponsor: Menschen für Kinder e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study Completion: 2021-10-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Premature babies with a gestational age <32 weeks of gestation and a birth weight <1500 g, who are treated in the neonatal intensive care unit of the University Hospital Giessen and are at least 72 hours old.
2. Requirement of non-invasive ventilation (CPAP / NIPPV.
3. FiO2 under CPAP / NIPPV 21 % - 60% with a PEEP of 5-8 cmH20
4. At least 4 hypoxemias (<80% SpO2) and / or apneas / bradycardias in the 12 hours prior to study entry.
5. In the 12 hours prior to study entry, the number of intervention-requiring events (defined as SpO2 <70% for> 1min or heart rate <100 / min for> 30 seconds) does not lead to an escalation of the non-invasive ventilation.
6. Written consent of the legal guardian is given.

Exclusion Criteria

1. Premature babies and newborns with severe malformations that significantly impair respiratory regulation (severe CNS malformations), lung function (e.g. pulmonary hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or the circulatory function (congenital cyanotic heart disease, septic shock).
2. Postnatal age <72 hours of life (often acute deterioration in the early phase of a respiratory distress syndrome and to protect the minimal handling principle in the critical phase to prevent intraventricular bleeding).
3. Start of treatment for an acute clinical infection <72 hours before study entry.
4. FiO2 under CPAP / NIPPV> 60% and / or PEEP> 8cmH20.
5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of intervention-requiring events (defined as SpO2 <70% for> 1 min. or Heart rate <100 / min. for> 30 seconds).
6. Planned blood transfusion or surgery during the study phase.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the absolute time as a percentage of oxygen saturation (SpO2) measured by pulse oximetry in the target oxygen saturation range (88-96%).