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

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

Complications of respiratory support [ Time Frame: 3 months ]
respiratory insufficiency, pneumothorax

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.

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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
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 Respiratory Distress Syndrome, Newborn Lung Diseases Respiratory Tract Diseases	Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases

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