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NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation

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ClinicalTrials.gov Identifier: NCT02842190
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
nilüfer okur, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:

Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.

Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.


Condition or disease Intervention/treatment Phase
Intubation Complication PreTerm Birth Device: NIPPV Not Applicable

Detailed Description:

In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.

Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.

Extubation failure was defined as: development of respiratory acidosis (blood gases with pH < 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 < 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.

Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.

The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
Study Start Date : January 15, 2016
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : October 15, 2019

Arm Intervention/treatment
Active Comparator: NIPPV
NIPPV after ekstubation
Device: NIPPV
after ekstubation

No Intervention: BIPAP
BIPAP after ekstubation



Primary Outcome Measures :
  1. Rate of extubation failure [ Time Frame: within 96 hours ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanically ventilated preterm infants with birthweight ≤1250 g

Exclusion Criteria:.

  • Infants with major congenital malformations, neuromuscular disease and lack of parental consent

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): NCT02842190


Contacts
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Contact: NİLUFER OKUR, dr +905065360059 n.matur@hotmail.com
Contact: Mehmet Buyuktiryaki +903123065072 mbuyuktiryaki@yahoo.com

Locations
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Turkey
Zekai Tahir Burak Maternity Teaching hospital Recruiting
Ankara, Turkey
Contact: Fatmanur Sari, Assosiace professor         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Study Director: Serife Suna Oguz Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Study Chair: Nurdan Uras Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: nilüfer okur, NEONATOLOGY, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02842190    
Other Study ID Numbers: NIPPV-2016
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Keywords provided by nilüfer okur, Zekai Tahir Burak Women's Health Research and Education Hospital:
Neonatal
NIPPV
BIPAP
Extubation failure
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications