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

Phase 4

Completed

• Conditions: Noninvasive Ventilation for Respiratory Distress Syndrome
• Interventions: Device: Nasal IMV (SLE); Device: Nasal CPAP (SLE)

• Registration Number: NCT01741129
• Lead Sponsor: Mehmet Yekta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-04
• Status Verified: 2013-01
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Intermittent Mandatory Ventilation (IMV)	Nasal IMV (SLE)	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 Continuous Positive Airway Pressure (CPAP)	Nasal CPAP (SLE)	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

Primary Outcome Measures

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

Name	Time	Method
Complications of respiratory support	3 months	respiratory insufficiency, pneumothorax

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital; 🇹🇷 Ankara, Turkey