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Clinical Trials/NCT01741129
NCT01741129
Completed
Phase 4

Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants

Mehmet Yekta1 site in 1 country200 target enrollmentNovember 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Noninvasive Ventilation for Respiratory Distress Syndrome
Sponsor
Mehmet Yekta
Enrollment
200
Locations
1
Primary Endpoint
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mehmet Yekta
Responsible Party
Sponsor Investigator
Principal Investigator

Mehmet Yekta

Zekai Tahir Burak Maternity and Teaching Hospital, Ankara

Zekai Tahir Burak Women's Health Research and Education Hospital

Eligibility Criteria

Inclusion Criteria

  • Gestational age 26-32 weeks
  • 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

  • Major congenital anomalies
  • Presence of cardiovascular instability
  • Intubation at admission to the NICU
  • Consent not provided or refused

Outcomes

Primary Outcomes

Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants

Time Frame: 3 months

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.

Secondary Outcomes

  • Complications of respiratory support(3 months)

Study Sites (1)

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