Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

Premature Neonate Clinical Trial

— HYFIVE  

Official title:

A Randomized Controlled Trial of pH-Controlled Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799875
• Other study ID #: UAB Neo 014
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: April 2021

Study information

• Verified date: April 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Premature Birth
• Premature Neonate

Intervention

Other:
• Higher permissive hypercapnia
pCO2 = 60mmHg with an upper limit = 75mmHg; pH = 7.20 from a capillary or arterial blood sample;
• Lower Permissive Hypercapnia
pCO2 = 40mmHg with an upper limit = 55mmHg; pH = 7.25 from a capillary or arterial blood sample;

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive Ventilator-free Days from Randomization to 28 Days after randomization	Number of days from time of randomization through 28 days after randomization	From randomization until 28 days after randomization
Secondary	All Causes of Death	All causes of death between randomization and anticipated 120 days after birth	Randomization to 120 days after birth
Secondary	Incidence of bronchopulmonary dysplasia "BPD"	Defined as need for supplemental oxygen per physiologic definition	Measured at 36 weeks postmenstrual age
Secondary	Open label treatment with postnatal steroids for bronchopulmonary dysplasia	Any treatment with postnatal steroids for bronchopulmonary dysplasia	Randomization to 120 days after birth
Secondary	Number of days alive, Continuous Positive Airway Pressure (CPAP)-free	Number of days alive, not receiving CPAP from randomization to 28 days post randomization	Randomization to 28 days post randomization
Secondary	Number of days alive, supplemental oxygen free	Number of days alive, not receiving oxygen from randomization to 28 days post randomization	Randomization to 28 days post randomization
Secondary	Neurodevelopmental Impairment	Results of Bayley Scales of Development, Version III	Measured at 22-26 months corrected gestational age
Secondary	Growth Indices-Weight	Weekly weights taken per clinical standard	Randomization to 28 days post randomization
Secondary	Growth Indices-Head Circumference	Weekly head circumferences taken per clinical standard	Randomization to 28 days post randomization
Secondary	Pulmonary Hypertension	Documentation of presence of pulmonary hypertension by echocardiogram	Routine echocardiogram performed at 28+/- 7 days after birth
Secondary	Intracranial Hemorrhage	Evidence of new or increased intracranial hemorrhage as documented on clinically obtained cranial ultrasounds closest to day 28 after birth	On routine head ultrasound closest to 28 days after birth