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Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

NCT02799875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

  • Premature Neonate

Interventions

OTHER

Higher permissive hypercapnia

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

OTHER

Lower Permissive Hypercapnia

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Colm P Travers, MB BCh BAo · University of Alabama at Birmingham

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799875 on ClinicalTrials.gov