Premature Neonate
Conditions
Keywords
respiratory distress syndrome, permissive hypercapnia, ventilator strategy
Brief summary
Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization.
Detailed description
22.0 to 36.6 weeks gestational age preterm infants with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to one of two ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization. After parental consent obtained, intubated, mechanically ventilated infants will be randomized by use of sequentially numbered sealed opaque envelopes to the treatment assignment. Randomized infants will be stratified by gestational age at delivery (\< 26 weeks, ≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). Multiple births will be randomized to the same group. The envelope will be opened only on days 7-14 when infant meets criteria. Clinicians will follow pre-specified algorithms of extubation and reintubation criteria to wean infants from mechanical ventilation. The ventilation algorithms may be set aside until the infant is deemed stable enough to allow resumption of the study algorithm. Infant will be extubated within 24 hours of meeting extubation criteria and documented on a single blood gas. A trial of extubation per attending physician is allowed independent of the trial protocol.All other care is per unit standard. Reports of routine follow-up after discharge in babies \< 27 weeks gestation will be obtained to determine neurodevelopmental impairment on this subset of babies.
Interventions
OTHERLower Permissive Hypercapnia
* pCO2 ≥ 40mmHg with an upper limit ≤ 55mmHg; * pH ≥ 7.25 from a capillary or arterial blood sample;
OTHERHigher permissive hypercapnia
* pCO2 ≥ 60mmHg with an upper limit ≤ 75mmHg; * pH ≥ 7.20 from a capillary or arterial blood sample;
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 14 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alive Ventilator-free Days from Randomization to 28 Days after randomization | From randomization until 28 days after randomization | Number of days from time of randomization through 28 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bronchopulmonary dysplasia BPD | Measured at 36 weeks postmenstrual age | Defined as need for supplemental oxygen per physiologic definition |
| Open label treatment with postnatal steroids for bronchopulmonary dysplasia | Randomization to 120 days after birth | Any treatment with postnatal steroids for bronchopulmonary dysplasia |
| Number of days alive, Continuous Positive Airway Pressure (CPAP)-free | Randomization to 28 days post randomization | Number of days alive, not receiving CPAP from randomization to 28 days post randomization |
| Number of days alive, supplemental oxygen free | Randomization to 28 days post randomization | Number of days alive, not receiving oxygen from randomization to 28 days post randomization |
| All Causes of Death | Randomization to 120 days after birth | All causes of death between randomization and anticipated 120 days after birth |
| Growth Indices-Weight | Randomization to 28 days post randomization | Weekly weights taken per clinical standard |
| Growth Indices-Head Circumference | Randomization to 28 days post randomization | Weekly head circumferences taken per clinical standard |
| Pulmonary Hypertension | Routine echocardiogram performed at 28+/- 7 days after birth | Documentation of presence of pulmonary hypertension by echocardiogram |
| Intracranial Hemorrhage | On routine head ultrasound closest to 28 days after birth | Evidence of new or increased intracranial hemorrhage as documented on clinically obtained cranial ultrasounds closest to day 28 after birth |
| Neurodevelopmental Impairment | Measured at 22-26 months corrected gestational age | Results of Bayley Scales of Development, Version III |
Countries
United States
Outcome results
None listed