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

PreTerm Birth Clinical Trial

Official title:

Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842190
• Other study ID #: NIPPV-2016
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: NILUFER OKUR, dr
• Phone: +905065360059
• Email: n.matur[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 15, 2019
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Mechanically ventilated preterm infants with birthweight =1250 g

Exclusion Criteria:.

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

Related Conditions & MeSH terms

• Intubation Complication
• Premature Birth
• PreTerm Birth

Intervention

Device:
• NIPPV
after ekstubation

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of extubation failure		within 96 hours