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OpenTrials
Completed

NCT Number: NCT01741129

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

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.

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Key information

Conditions

Noninvasive Ventilation for Respiratory Distress Syndrome

Age range

Up to 2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal CPAP (SLE)

Device

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

Other names: SLE 2000, SLE 5000

Nasal IMV (SLE)

Device

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

Other names: SLE 2000, SLE 5000

Primary outcomes

  1. 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

  1. Complications of respiratory support

    Time frame: 3 months

    respiratory insufficiency, pneumothorax

Sponsors and collaborators

Lead sponsor

Mehmet Yekta

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2012
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.