South Tees NHS Trust
Middlesbrough, United Kingdom
Location status: Recruiting
NCT Number: NCT06705257
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.
Interested in participating?
Request Info22 week–32 week
All sexes
Interventional
Not applicable
Middlesbrough, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: total study of 280 minutes
Changes in End expiratory Lung Impedance scores
Time frame: 280minutes
Changes in functional lung scores in percentage varying levels of CDP.
Time frame: 280 minutes
Changes in silence spaces with varying levels of CDP.
Time frame: Total 280 minutes of study time
Changes in oxygen saturation (SpO2 in percentage) during the study period.
Time frame: Total study time of 280 minutes
Changes in carbon dioxide levels as measured by transcutaneous carbon dioxide levels (TCO2) in kilopascal.
Time frame: Total study time of 280 minutes
Changes in fraction of inspiratory oxygen (Fio2) levels during the study.
Time frame: Total study time of 280minutes
Changes in blood pressure (if measured) during the study procedure.
Contact information is provided by the study sponsor or research team.
Amanda Forster
CONTACT
Prakash Kannan Loganathan, MD
CONTACT
South Tees Hospitals NHS Foundation Trust
Other
EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
Acronym: [PEOPLE]
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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