Status:
UNKNOWN
Automatic Oxygen Control (SPOC) in Preterm Infants
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Fritz Stephan GmbH
Conditions:
Infantile Respiratory Distress Syndrome
Ventilator Lung; Newborn
Eligibility:
All Genders
Up to 34 years
Phase:
NA
Brief Summary
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive ...
Detailed Description
BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigato...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- gestational age at birth \<34+1/7weeks and
- invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and
- Fraction of inspired oxygen above 0.21 before inclusion and
- more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion and
- parental written informed consent
- Exclusion Criteria (any of the following):
- congenital pulmonary anomalies
- congenital heart defects influencing SpO2 (i.e. cyanotic heart defects)
- right-to -left shunt through a PDA
- Severe neonatal complications during study period (sepsis, necrotising enterocolitis)
- diaphragmatic hernia or other diaphragmatic disorders
Exclusion
Key Trial Info
Start Date :
August 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03785899
Start Date
August 3 2018
End Date
August 1 2020
Last Update
January 4 2019
Active Locations (1)
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1
Department of Neonatology, University Children's Hospital
Tübingen, Germany, 72076