Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Bronchopulmonary Dysplasia Clinical Trial

— NIV  

Official title:

Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01989442
• Other study ID #: Map-NIV Trial
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: January 14, 2015
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Ankara University
• Contact: Ankara University
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.

The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.

Description:

Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit

Exclusion Criteria:

• who are intubated in delivery room or neonatal intensive care unit before randomization

• with congenital anomaly

• patients who require NIV more than 3 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Device:
• binasal prongs
patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support
• nasal mask
patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22. — View Citation

McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bronchopulmonary dysplasia	oxygen or pressure requirement on postmenstrual 36 weeks of gestational age	1 year	No
Other	septal trauma rate	any destruction on nose that require treatment after use of NIV	1 year	Yes
Primary	failure of NIV	patients who require endotracheal intubation after NIV treatment	1 year	No
Secondary	ventilation duration	both NIV and mechanical ventilation durations will be evaluated	3 days	No