Comparison of Effectiveness of Nasal CPAP and Nasal IMV i... | NCT01741129

NCT01741129

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasal Continuous Positive Airway Pressure (CPAP)	Active Comparator	After 2 hours evaluation: Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose	Device: Nasal CPAP (SLE)
Nasal Intermittent Mandatory Ventilation (IMV)	Active Comparator	After 2 hours evaluation: Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose	Device: Nasal IMV (SLE)

Name	Type	Description	Arm Group Labels	Other Names
Nasal CPAP (SLE)	Device	PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute	Nasal Continuous Positive Airway Pressure (CPAP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants	If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.	3 months

Measure	Description	Time Frame
Complications of respiratory support	respiratory insufficiency, pneumothorax	3 months

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Zekai Tahir Burak Maternity Teaching Hospital		Ankara		06230	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26553376	Derived	Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.