Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 days
Maximum Age: 2 months
Healthy Volunteers: f
View:

• Preterm infants born \<34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days

• Infants aged between 2 days and 2 months at time of study

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Contact Information
Primary
Oishi Sikdar
oishi.sikdar2@nhs.net
07901931550
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2024-08-01
Participants
Target number of participants: 21
Treatments
Experimental: Pre-term infants requiring primary respiratory support before intubation
Infants \<34 weeks gestational age who require non-invasive respiratory support who may go on to require invasive ventilation.
Experimental: Pre-term infants requiring respiratory support after extubation
Infants \<34 weeks gestational age who were previously invasively ventilated and are currently being weaned onto non-invasive respiratory support and eventually into self-ventilating in room air.
Experimental: Pre-term infants requiring respiratory support after seven days
Infants \<34 weeks gestational age who have an ongoing need for non-invasive respiratory support after seven days of life and are likely to develop bronchopulmonary dysplasia.
Related Therapeutic Areas
Sponsors
Leads: King's College Hospital NHS Trust

This content was sourced from clinicaltrials.gov