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Clinical Trials/NCT06705257
NCT06705257
Not yet recruiting
Not Applicable

EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY

South Tees Hospitals NHS Foundation Trust0 sites30 target enrollmentJuly 15, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreTerm Neonate
Sponsor
South Tees Hospitals NHS Foundation Trust
Enrollment
30
Primary Endpoint
Changes in EIT parameters
Status
Not yet recruiting
Last Updated
11 months ago

Overview

Brief Summary

Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed. Lungs of preterm babies will often collapse in between breathing due to lung immaturity. Applying gentle pressure, using nasal device through their nostril or through the breathing tube helps to prevent this lung collapse. This would help in air-oxygen going to lungs and also makes the babies breathing more comfortable. This gentle pressure is medically called as PEEP/CPAP and could be delivered by breathing machine (ventilator) and CPAP machine, collectively called as "continuous distending pressure (CDP)".

Those babies breathing on their own and receiving inadequate CDP would need more breathing support by placing them on breathing machine (ventilator). The longer the baby receives breathing machine support, higher chance of lung injury . Preterm infants who are already on breathing machine, providing sub optimal PEEP/CPAP could also lead to lung damage. Providing optimal PEEP/CPAP could prevent these negative outcomes. Currently there is not enough evidence to suggest optimal PEEP/CPAP in preterm infants. Neonatal units all around the world uses PEEP/CPAP ranging from 4 to 10cm H20 based on their unit practice. Currently available investigations provide limited one time information (e.g. Chest X-ray) regarding whether baby is receiving optimal PEEP/CPAP. Electrical Impedance Tomography (EIT) is a new technology which could provide better information regarding the pressure delivered. Also, this device would provide continuous information as if the clinicians are doing continuous chest X-ray but without any radiation. In this study, the team will assess the effect of different levels of PEEP/CPAP (4 to 10cm H20) on prevention of lung collapse using EIT. This would be studied in premature infants who are on breathing machine support and CPAP machine support.

Registry
clinicaltrials.gov
Start Date
July 15, 2025
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in EIT parameters

Time Frame: 280minutes

Changes in functional lung scores in percentage varying levels of CDP.

Changes in EIT

Time Frame: 280 minutes

Changes in silence spaces with varying levels of CDP.

Secondary Outcomes

  • Secondary outcomes(Total 280 minutes of study time)
  • Secondary outcome measure(Total study time of 280 minutes)
  • Secondary outcome(Total study time of 280minutes)

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