Status:
COMPLETED
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
Lead Sponsor:
Takeda
Conditions:
Non-invasive Ventilatory Support
Infant Respiratory Distress Syndrome
Eligibility:
All Genders
27-36 years
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 dur...
Eligibility Criteria
Inclusion
- 1\. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).
- 2\. Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW.
- 3\. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.
- 4\. CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O. 5. Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0.
Exclusion
- 1\. FiO2 \> 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0).
- 2\. Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study.
- 3\. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01861795
Start Date
June 1 2013
End Date
March 1 2014
Last Update
August 22 2014
Active Locations (3)
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1
Hanover, Germany
2
Lübeck, Germany
3
Nuremberg, Germany