Clinical trial NCT02681315: Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants
Official title: HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity, Mechanical Ventilation
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically ventilated preterm infants.

Detailed description: HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a recent international survey on periextubation practices in extremely preterm infants, nCPAP was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have efficacy and safety similar to those of nCPAP when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC to prevent extubation failure remains to be known.

This RCT aims to compare the efficacy and safety of postextubation respiratory support via HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. We hypothesized that postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.

Eligibility criteria: Inclusion Criteria:

* Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.

Exclusion Criteria:

* Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations

Primary outcomes:
measure: Extubation failure
timeFrame: the 7 days after extubation
Secondary outcomes:
measure: Mortality
timeFrame: within the 96 hour post-extubation period or at any time after with expected average of 5 weeks
measure: Total duration of mechanical ventilation
timeFrame: During NICU admission with expected average of 5 weeks
measure: Total duration of oxygen supplementation
timeFrame: During NICU admission with expected average of 5 weeks
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: at 36 weeks' post-menstrual age.
measure: Severe BPD
timeFrame: at 36 weeks' post-menstrual age.
measure: The combined outcome variables of death before 36 weeks PMA or BPD
timeFrame: at 36 weeks' post-menstrual age.
measure: The combined outcome variables of death before 36 weeks PMA or severe BPD
timeFrame: at 36 weeks' post-menstrual age
measure: Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity)
timeFrame: baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 5 weeks
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Neonatal Intensive Care Unit, Mansoura University Children Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University Children"s Hospital
name: Hesham Abdel-Hady
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Mandari H, Shalish W, Dempsey E, Keszler M, Davis PG, Sant'Anna G. International survey on periextubation practices in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5):F428-31. doi: 10.1136/archdischild-2015-308549. Epub 2015 Jun 10.
citation: Collaborative Group for the Multicenter Study on Heated Humidified High-flow Nasal Cannula Ventilation. [Efficacy and safety of heated humidified high-flow nasal cannula for prevention of extubation failure in neonates]. Zhonghua Er Ke Za Zhi. 2014 Apr;52(4):271-6. Chinese.
citation: Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.
citation: Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.