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NCT06705257: [PEOPLE]

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

Not yet recruiting NA Last updated 16 May 2025
What this trial tests

NA trial testing Studying the effects of varying levels of PEEP using Electrical impedance tomography in PreTerm Neonate in 30 participants. Not yet recruiting.

Timeline
15 July 2025
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorSouth Tees Hospitals NHS Foundation Trust
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment30
Start date15 July 2025
Primary completion31 December 2025
Estimated completion31 December 2025

Drugs / interventions tested

Conditions studied

Sponsor

South Tees Hospitals NHS Foundation Trust

Who can join

Adults 22 Weeks to 32 Weeks, any sex, with PreTerm Neonate or Positive End Expiratory Pressure (PEEP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for PreTerm Neonate

Currently open trials in the same condition.

Other South Tees Hospitals NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06705257.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing