Prematurity, Mechanical Ventilation Clinical Trial
Official title:
HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial
| NCT number | NCT02681315 |
| Other study ID # | MS/15.10.41 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | January 2018 |
| Verified date | September 2017 |
| Source | Mansoura University Children Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 30 Days |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Neonatal Intensive Care Unit, Mansoura University Children Hospital | Mansourah | Dakahlia |
| Lead Sponsor | Collaborator |
|---|---|
| Mansoura University Children Hospital |
Egypt,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Extubation failure | Extubation failure criteria will be defined as follows: Apnea (respiratory pause >20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation. Respiratory acidosis with pH <7.25 and Peripheral arterial oxygen saturation (PaCO2) >65 mmHg. ( >15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate <60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team. |
the 7 days after extubation | |
| Secondary | Mortality | Death within the 96 hour post-extubation period or at any time after randomization. | within the 96 hour post-extubation period or at any time after with expected average of 5 weeks | |
| Secondary | Total duration of mechanical ventilation | Total duration of mechanical ventilation during NICU admission | During NICU admission with expected average of 5 weeks | |
| Secondary | Total duration of oxygen supplementation | Total duration of oxygen supplementation during NICU admission | During NICU admission with expected average of 5 weeks | |
| Secondary | Bronchopulmonary dysplasia (BPD) | BPD defined by oxygen requirement at 36 weeks' post-menstrual age. | at 36 weeks' post-menstrual age. | |
| Secondary | Severe BPD | Severe BPD defined as oxygen requirement with fraction of inspired oxygen (FiO2) >0.30 or need for positive pressure support at 36 weeks' post-menstrual age. | at 36 weeks' post-menstrual age. | |
| Secondary | The combined outcome variables of death before 36 weeks PMA or BPD | The combined outcome variables of death before 36 weeks PMA or BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD. | at 36 weeks' post-menstrual age. | |
| Secondary | The combined outcome variables of death before 36 weeks PMA or severe BPD | The combined outcome variables of death before 36 weeks' post-menstrual age (PMA) or severe BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD. | at 36 weeks' post-menstrual age | |
| Secondary | Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity) | The occurrence of neonatal morbidities occurring before, during the 96 hours post-extubation, and at any time thereafter will be documented (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity). | baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 5 weeks |