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

Mehmet Yekta

Status and phase: Completed; Phase 4

Conditions: Noninvasive Ventilation for Respiratory Distress Syndrome

Treatments: Device: Nasal CPAP (SLE); Device: Nasal IMV (SLE)

Study type: Interventional

Funder types: Other

Identifiers

NCT01741129

ZTB2611

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: Under 2 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Nasal Continuous Positive Airway Pressure (CPAP)

Active Comparator group

Description:

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

Treatment:

Device: Nasal CPAP (SLE)

Nasal Intermittent Mandatory Ventilation (IMV)

Active Comparator group

Description:

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

Treatment:

Device: Nasal IMV (SLE)