Skip to main content
OpenTrials
Completed

NCT Number: NCT02799875

Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Neonate Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

7 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher permissive hypercapnia

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

Lower Permissive Hypercapnia

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

Primary outcomes

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

    Time frame: From randomization until 28 days after randomization

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

Secondary outcomes

  1. All Causes of Death

    Time frame: Randomization to 120 days after birth

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

  2. Incidence of bronchopulmonary dysplasia "BPD"

    Time frame: Measured at 36 weeks postmenstrual age

    Defined as need for supplemental oxygen per physiologic definition

  3. Open label treatment with postnatal steroids for bronchopulmonary dysplasia

    Time frame: Randomization to 120 days after birth

    Any treatment with postnatal steroids for bronchopulmonary dysplasia

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

    Time frame: Randomization to 28 days post randomization

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

  5. Number of days alive, supplemental oxygen free

    Time frame: Randomization to 28 days post randomization

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

  6. Neurodevelopmental Impairment

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

    Results of Bayley Scales of Development, Version III

  7. Growth Indices-Weight

    Time frame: Randomization to 28 days post randomization

    Weekly weights taken per clinical standard

  8. Growth Indices-Head Circumference

    Time frame: Randomization to 28 days post randomization

    Weekly head circumferences taken per clinical standard

  9. Pulmonary Hypertension

    Time frame: Routine echocardiogram performed at 28+/- 7 days after birth

    Documentation of presence of pulmonary hypertension by echocardiogram

  10. Intracranial Hemorrhage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: HYFIVE

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2016
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.