Clinical trial NCT02842190: NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
Official title: Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation Complication
PreTerm Birth
Keywords: Neonatal
NIPPV
BIPAP
Extubation failure
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of extubation failure
timeFrame: within 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching hospital
Study officials:
affiliation: Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
name: Serife Suna Oguz
role: STUDY_DIRECTOR
affiliation: Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
name: Nurdan Uras
role: STUDY_CHAIR
References:
citation: Okur N, Buyuktiryaki M, Sari FN, Dizdar EA, Oguz SS. Ventilator-delivered nasal intermittent positive pressure ventilation versus nasal biphasic positive airway pressure following extubation in infants </=1250 g birth weight: a randomized trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):752-758. doi: 10.1080/14767058.2020.1731462. Epub 2020 Feb 27.