Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482040
Status:
TERMINATED
Last Update Posted:
2007-08-24
First Post:
2007-06-01
Brief Title:
Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruiting took longer than expected due to a lack of eligible patients very strong inclusion and exclusion criterias
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 study is to evaluate four different nasal continuous pressure systems which are usually applied on our neonatal intensive care unit with regard of their effect on bradycardia and desaturations in preterm infants
Detailed Description:
BACKGROUND
Apnea of prematurity AOP is a common problem in preterm infants Nasal respiratory support using either Continuous Positive Airway Pressure CPAP or Intermittent Mandatory Ventilation IMV are among others widely used treatments Which of the different systems is the most efficient however is unclear
OBJECTIVE
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants
METHODS
In a prospective randomized cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems 1 a conventional IMV-System Stephanie Stephan GmbH Germany with PIP 15 cmH2O RR 10min delivering CPAP via short binasal prongs Hudson RCI USA 2 the Infant-Flow-System EME Ltd Great Britain with CPAP delivery via short binasal prongs 3 the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O RR 10min and 4 a nasal underwater bubble CPAP with application via binasal prongs Hudson RCI USA
All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O Each study lasts 24 hours during which chest wall and abdominal movements SaO2 tcPCO2 ECG esopha-gus pressure and CPAP-IMV-pressure will be recorded continuously Infants will be studied in room air in a 15 head tilt prone position while being treated with caffeine 3mgkgd
PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia heart rate 80min and desaturation SaO2 80 per hour
Apnea of prematurity AOP is a common problem in preterm infants Nasal respiratory support using either Continuous Positive Airway Pressure CPAP or Intermittent Mandatory Ventilation IMV are among others widely used treatments Which of the different systems is the most efficient however is unclear
OBJECTIVE
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants
METHODS
In a prospective randomized cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems 1 a conventional IMV-System Stephanie Stephan GmbH Germany with PIP 15 cmH2O RR 10min delivering CPAP via short binasal prongs Hudson RCI USA 2 the Infant-Flow-System EME Ltd Great Britain with CPAP delivery via short binasal prongs 3 the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O RR 10min and 4 a nasal underwater bubble CPAP with application via binasal prongs Hudson RCI USA
All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O Each study lasts 24 hours during which chest wall and abdominal movements SaO2 tcPCO2 ECG esopha-gus pressure and CPAP-IMV-pressure will be recorded continuously Infants will be studied in room air in a 15 head tilt prone position while being treated with caffeine 3mgkgd
PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia heart rate 80min and desaturation SaO2 80 per hour
Study Oversight
Has Oversight DMC:
None
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?:
None