Clinical trial NCT02799875: Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
Official title: A Randomized Controlled Trial of pH-Controlled Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Neonate
Keywords: respiratory distress syndrome
permissive hypercapnia
ventilator strategy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 130
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alive Ventilator-free Days from Randomization to 28 Days after randomization
timeFrame: From randomization until 28 days after randomization
Secondary outcomes:
measure: All Causes of Death
timeFrame: Randomization to 120 days after birth
measure: Incidence of bronchopulmonary dysplasia "BPD"
timeFrame: Measured at 36 weeks postmenstrual age
measure: Open label treatment with postnatal steroids for bronchopulmonary dysplasia
timeFrame: Randomization to 120 days after birth
measure: Number of days alive, Continuous Positive Airway Pressure (CPAP)-free
timeFrame: Randomization to 28 days post randomization
measure: Number of days alive, supplemental oxygen free
timeFrame: Randomization to 28 days post randomization
measure: Neurodevelopmental Impairment
timeFrame: Measured at 22-26 months corrected gestational age
measure: Growth Indices-Weight
timeFrame: Randomization to 28 days post randomization
measure: Growth Indices-Head Circumference
timeFrame: Randomization to 28 days post randomization
measure: Pulmonary Hypertension
timeFrame: Routine echocardiogram performed at 28+/- 7 days after birth
measure: Intracranial Hemorrhage
timeFrame: On routine head ultrasound closest to 28 days after birth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, MB BCh BAo
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
References: