Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

University of Alabama at Birmingham130 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Premature Neonate

Interventions

Higher permissive hypercapniaOTHER

* pCO2 ≥ 60mmHg with an upper limit ≤ 75mmHg; * pH ≥ 7.20 from a capillary or arterial blood sample;

Lower Permissive HypercapniaOTHER

* pCO2 ≥ 40mmHg with an upper limit ≤ 55mmHg; * pH ≥ 7.25 from a capillary or arterial blood sample;

Eligibility

Sex: ALLMin age: 7 DaysMax age: 14 Days

Medical Language ↔ Plain English

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

Locations (1)

UAB

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Alive Ventilator-free Days from Randomization to 28 Days after randomization

Number of days from time of randomization through 28 days after randomization

Time frame: From randomization until 28 days after randomization

Secondary Outcomes

All Causes of Death

All causes of death between randomization and anticipated 120 days after birth

Time frame: Randomization to 120 days after birth

Incidence of bronchopulmonary dysplasia "BPD"

Defined as need for supplemental oxygen per physiologic definition

Time frame: Measured at 36 weeks postmenstrual age

Open label treatment with postnatal steroids for bronchopulmonary dysplasia

Any treatment with postnatal steroids for bronchopulmonary dysplasia

Time frame: Randomization to 120 days after birth

Number of days alive, Continuous Positive Airway Pressure (CPAP)-free

Number of days alive, not receiving CPAP from randomization to 28 days post randomization

Time frame: Randomization to 28 days post randomization

Number of days alive, supplemental oxygen free

Number of days alive, not receiving oxygen from randomization to 28 days post randomization

Time frame: Randomization to 28 days post randomization

Neurodevelopmental Impairment

Results of Bayley Scales of Development, Version III

Time frame: Measured at 22-26 months corrected gestational age

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.