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

March 7, 2014 updated by: Mehmet Yekta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Zekai Tahir Burak Maternity Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • SLE 2000, SLE 5000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of respiratory support
Time Frame: 3 months
respiratory insufficiency, pneumothorax
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Yekta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (ESTIMATE)

December 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTB2611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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