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Different Levels of BiPAP

NCT06421519 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-06-11

No results posted yet for this study

Summary

Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing. The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure (BiPAP), a support which gives two levels of support (pressure) to premature infants.

The study is investigating which upper pressure gives the best support, that is results in the baby having to breathe less hard (work of breathing).

Researchers will measure the work of breathing using a small catheter. Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each. In between each upper level they will receive the standard upper pressure for 20 minutes.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

OTHER

BiPAP setting

Infants in this arm of the study will each rotate through three different BiPAP settings. The following BiPAP settings will be used: 13cmH2O / 5cmH2O, 10cmH2O / 5cmH2O, 7cmH2O / 5cmH2O

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Theodore Dassios · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
2 Days
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • United Kingdom

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 NCT06421519 on ClinicalTrials.gov