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Clinical Trials/DRKS00023923
DRKS00023923
Recruiting
Phase 4

Effects of different inspiratory times on oxygenation and ventilation parameters in preterm infants with frequent fluctuations in arterial oxygen saturations - a randomized controlled trial - Not applicable

Abteilung Allgemeine Pädiatrie und Neonatologie0 sites24 target enrollmentDecember 28, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Apnea of Prematurity
Sponsor
Abteilung Allgemeine Pädiatrie und Neonatologie
Enrollment
24
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 28, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Abteilung Allgemeine Pädiatrie und Neonatologie

Eligibility Criteria

Inclusion Criteria

  • 1\. premature infants (birth weight \<1500g) who are treated in the neonatal intensive care unit or the intermediate care area
  • 2\. need of non\-invasive ventilation (CPAP/NIPPV)
  • 3\. at least 4 hypoxemias (\< 80% SpO2\) or 4 apneas/bradycardias in 8 hours before study entry
  • 4\. written informed consent from 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 cyanotic cardiac disease, severe septic shock)
  • 2\. postnatal age \<120h (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 level \>10mg/l) with or without circulatory insufficiency, or positive blood culture
  • 4\. Anticipated blood transfusion during the study phase

Outcomes

Primary Outcomes

Not specified

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