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The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).
Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.
In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.
Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-nIMV | Experimental | nIMV synchronized using abdominal pressure capsule sensor device |
|
| nIMV | Placebo Comparator | non-synchronized nasal intermittent mandatory ventilation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-nIMV | Device | Synchronization of nasal breaths to infant's own respiratory effort |
|
| Measure | Description | Time Frame |
|---|---|---|
| phasic esophageal pressure deflection | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral oxygen saturation | 4 hours | |
| Arterial oxygen saturation | 4 hours |
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Inclusion Criteria:
Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
Exclusion Criteria:
• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helmut Hummle, Prof. Dr. | Contact | 0731-500-57168 | helmut.hummler@uniklinik-ulm.de | |
| Li Huang, Master | Contact | 015776891592 | hhuangli@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hummler Helmut, Prof. Dr | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital University of Ulm | Recruiting | Ulm | Baden-Wüttemberg | 89075 | Germany |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |