Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants (HYFIVE)
Premature Neonate
About this trial
This is an interventional treatment trial for Premature Neonate focused on measuring respiratory distress syndrome, permissive hypercapnia, ventilator strategy
Eligibility Criteria
Inclusion Criteria:
- Gestational age at least 22 but less than 37 weeks;
- Intubated on mechanical ventilation for respiratory distress syndrome on days 7-14 after birth;
- Admitted to Neonatal Intensive Care Unit before 7 days after birth;
- Informed consent per parent(s)
Exclusion Criteria:
- Major malformation
- Neuromuscular condition that affects respiration
- Terminal illness
- Attending physician has made a decision to withhold or limit support for the infant
Sites / Locations
- UAB
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Higher permissive hypercapnia
Lower permissive hypercapnia
Extubation criteria: partial pressure carbon dioxide (pCO2) ≥ 60mmHg with an upper limit ≤ 75mmHg; pH ≥ 7.20; oxygen saturation (SpO2) ≥ 88% with fraction of inspired oxygen (FiO2) ≤ 0.50; mean airway pressure (MAP) < 8 cm H2O, ventilator rate ≤ 20 bpm, amplitude < 2X MAP if on high frequency ventilation (HFV); hemodynamically stable (clinically acceptable blood pressure and perfusion per clinical team opinion). In addition, reintubation may occur if any of the following are met: PCO2 > 75mmHg; pH < 7.20; FiO2 ≥0.80 required to maintain SpO2 ≥ 88% for one hour; hemodynamic instability; clinically defined shock; repetitive apnea (> 1 episode per hour) requiring bag and mask ventilation; sepsis; and/or need for surgery.
Extubation criteria: pCO2 ≥ 40mmHg with an upper limit ≤ 55mmHg; pH ≥ 7.25; SpO2 ≥ 88% with FiO2 ≤ 0.50; mean airway pressure (MAP) < 8 cm H2O, ventilator rate ≤ 20 bpm, amplitude < 2X MAP if on high frequency ventilation (HFV); hemodynamically stable (clinically acceptable blood pressure and perfusion per clinical team opinion). In addition, reintubation may occur if any of the following are met: PCO2 > 55mmHg; pH < 7.25; FiO2 ≥0.80 required to maintain SpO2 ≥ 88% for one hour; hemodynamic instability; clinically defined shock; repetitive apnea (> 1 episode per hour) requiring bag and mask ventilation; sepsis; and/or need for surgery.