An interventional study of Studying the effects of varying levels of PEEP using Electrical impedance tomography in PreTerm Neonate, Positive End Expiratory Pressure (PEEP) and Lung Recruitment, sponsored by South Tees Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 22 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by South Tees Hospitals NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →South Tees Hospitals NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Exclusion criteria
Diagnostic Test: Studying the effects of varying levels of PEEP using Electrical impedance tomography
Feasibility of using EIT, to study the effect of varying levels of PEEP/Continous distending pressure on lung recruitment as measured by changes in functional lung scores and silent spaces in preterm infants (\<32 weeks) who are on mechanical ventilation or receiving primary or post extubation CPAP support.
Changes in EIT parameters
Changes in End expiratory Lung Impedance scores
Time frame: total study of 280 minutes
Changes in EIT parameters
Changes in functional lung scores in percentage varying levels of CDP.
Time frame: 280minutes
Changes in EIT
Changes in silence spaces with varying levels of CDP.
Time frame: 280 minutes
Secondary outcomes
Changes in oxygen saturation (SpO2 in percentage) during the study period.
Time frame: Total 280 minutes of study time
Secondary outcome measure
Changes in carbon dioxide levels as measured by transcutaneous carbon dioxide levels (TCO2) in kilopascal.
Time frame: Total study time of 280 minutes
Secondary outcome
Changes in fraction of inspiratory oxygen (Fio2) levels during the study.
Time frame: Total study time of 280 minutes
Secondary outcome
Changes in blood pressure (if measured) during the study procedure.
Time frame: Total study time of 280minutes
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After the main study publication
Access criteria: With valid study protocol and ethical approval.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
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South Tees Hospitals NHS Foundation Trust