NCT01861795

Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 27 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-invasive Ventilatory Support
• Infant Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	Preterm Neonates	Preterm Neonates

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-05-24
• Last updated: 2014-08-22

Locations

3 sites across 1 country: Germany