Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-28 @ 9:20 AM
Study NCT ID:
NCT01861795
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2013-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
Sponsor:
Takeda
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1141-9396 | REGISTRY | WHO | View |