Infant Respiratory Distress Syndrome Clinical Trial
Official title:
An Oligo-center Observational Study to Collect Data in Preterm Neonates Born at or Above 27+0 Weeks of Gestational Age Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
The objective of this study is to collect data on vital signs, oxygen requirements and other
data in preterm infants who are breathing stably on non-invasive ventilatory support. The
data obtained during this study will be used to compare data obtained in a future study that
will add a new medicinal product in combination with non-invasive ventilatory support to
accelerate lung development in preterm infants.
The study will enroll approximately 40 patients. Participants will not be receiving any
investigational medicinal product or device in this study.
All participants will have vital signs, oxygen requirements and other data collected
continuously throughout the study.
This multi-centre trial will be conducted in Germany. The overall time to participate in
this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of
gestational age or until they are discharged from the hospital.
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Observational Model: Case-Only, Time Perspective: Prospective
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