Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
NCT ID: NCT01741129
Last Updated: 2014-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nasal Continuous Positive Airway Pressure (CPAP)
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
Nasal CPAP (SLE)
PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
Nasal Intermittent Mandatory Ventilation (IMV)
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
Nasal IMV (SLE)
PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
Interventions
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Nasal CPAP (SLE)
PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
Nasal IMV (SLE)
PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
The criteria for failure were met by at least 1 of the following:
* pH: 7.10 and PaCO2: 70 mm Hg
* Recurrent apnea with \>3 episodes (Prophylactic caffeine were used in all infants)
* Single episode of apnea that required bag-and-mask ventilation
* PaO2: 50 mmHg with a fraction of inspired oxygen of \>0.5.
Exclusion Criteria
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused
2 Hours
ALL
No
Sponsors
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Mehmet Yekta
OTHER
Responsible Party
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Mehmet Yekta
Zekai Tahir Burak Maternity and Teaching Hospital, Ankara
Locations
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Zekai Tahir Burak Maternity Teaching Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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ZTB2611
Identifier Type: -
Identifier Source: org_study_id
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