Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
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|ClinicalTrials.gov Identifier: NCT01861795|
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : August 22, 2014
|Condition or disease||Intervention/treatment|
|Non-invasive Ventilatory Support Infant Respiratory Distress Syndrome||Other: Preterm Neonates|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Preterm neonates born at or above 27+0 weeks of gestational age sufficiently stable on nasal continuous positive airway pressure (CPAP) will be treated by standard of care.
Other: Preterm Neonates
- Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2) [ Time Frame: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0 ]Fraction of inspired oxygen (FiO2) is the amount of oxygen in the ventilator outlet gas flow.
- Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96% [ Time Frame: T0 and at 0.25, 0.5, 0.75 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 4, 4.25. 4.5, 4.74, 5, 5.25, 5.75, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 hours ]Saturation of peripheral oxygen is the amount of oxygen bound to hemoglobin in the blood expressed as a percentage of the maximal binding capacity. It will be measured with a pulse oximeter.
- Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours [ Time Frame: T0 to 98 hours ]CPAP failure is reached when FiO2 ≥ 50% is need for more than 15 minutes to reach 90% saturation of peripheral oxygen (SpO2).
- Percentage of participants requiring instillation of an approved surfactant preparation [ Time Frame: Gestational week (GW) 36+6 days ]
- Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36 [ Time Frame: Gestational Week 36 ]Bronchopulmonary dysplasia (BPD) is defined as a lung injury in preterm neonates resulting from oxygen toxicity and/or mechanical ventilation (elevated air pressure).
- Respiratory rate over time [ Time Frame: T0 to Gestational Week 36 ]
- Percentage of participants with a positive room-air challenge test at Gestational Week 36 [ Time Frame: Gestational Week 36 ]The room-air challenge test is defined as a weaning attempt allowing the participant to breath non-pressurized room air for 30 minutes. If a blood oxygen saturation of ≥90% is achieved during weaning, the weaning was successful and patients are considered to be free of bronchopulmonary dysplasia and need no further ventilation support.
- Mortality rate [ Time Frame: T0 to Gestational Week 36+6 days ]
- Time under Continuous Positive Airway Pressure ventilatory support [ Time Frame: T0 to Gestational Week 36+6 days ]
- Time of additional oxygen demand (FiO2 > 21%) [ Time Frame: T0 to Gestational Week 36+6 days ]
- Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU) [ Time Frame: T0 to Gestational Week 36+6 days ]
- Time of intubation for mechanical ventilation [ Time Frame: T0 to Gestational Week 36+6 days ]
- Time on any ventilation support [ Time Frame: T0 to Gestational Week 36+6 days ]Any ventilation support includes continuous positive airway pressure (CPAP), manual support and intubation.
- Days in hospital [ Time Frame: From T0 to Gestational Week 36+6 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861795
|Study Director:||Medical Director||Takeda|