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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01741129
Enrollment
200
Registered
2012-12-04
Start date
2012-11-30
Completion date
2013-11-30
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Ventilation for Respiratory Distress Syndrome

Keywords

Nasal CPAP, Nasal IMV, Surfactant, Preterm infants

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.

Interventions

DEVICENasal CPAP (SLE)

PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute

DEVICENasal IMV (SLE)

PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute

Sponsors

Mehmet Yekta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants3 monthsIf 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

MeasureTime frameDescription
Complications of respiratory support3 monthsrespiratory insufficiency, pneumothorax

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026