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

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ClinicalTrials.gov Identifier: NCT01741129
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Condition or disease Intervention/treatment Phase
Noninvasive Ventilation for Respiratory Distress Syndrome Device: Nasal CPAP (SLE) Device: Nasal IMV (SLE) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Active Comparator: Nasal Continuous Positive Airway Pressure (CPAP)

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
Device: Nasal CPAP (SLE)
PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
Other Name: SLE 2000, SLE 5000

Active Comparator: Nasal Intermittent Mandatory Ventilation (IMV)

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
Device: Nasal IMV (SLE)
PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
Other Name: SLE 2000, SLE 5000




Primary Outcome Measures :
  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 Outcome Measures :
  1. Complications of respiratory support [ Time Frame: 3 months ]
    respiratory insufficiency, pneumothorax



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Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741129


Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Mehmet Yekta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital, Ankara, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT01741129     History of Changes
Other Study ID Numbers: ZTB2611
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: January 2013
Keywords provided by Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital:
Nasal CPAP
Nasal IMV
Surfactant
Preterm infants
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents