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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm with increasing and decreasing PEEP levels | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Studying the effects of varying levels of PEEP using Electrical impedance tomography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EIT parameters | Changes in End expiratory Lung Impedance scores | total study of 280 minutes |
| Changes in EIT parameters | Changes in functional lung scores in percentage varying levels of CDP. | 280minutes |
| Changes in EIT | Changes in silence spaces with varying levels of CDP. | 280 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes | Changes in oxygen saturation (SpO2 in percentage) during the study period. | Total 280 minutes of study time |
| Secondary outcome measure | Changes in carbon dioxide levels as measured by transcutaneous carbon dioxide levels (TCO2) in kilopascal. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prakash Kannan Loganathan, MD | Contact | +447481492632 | pkannanloganathan@nhs.net | |
| Amanda Forster | Contact | +44 1642 854872 | amanda.forster2@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Jackie Mitchell | South Tees NHS foundation trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Tees NHS Trust | Recruiting | Middlesbrough | United Kingdom |
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After the main study publication
With valid study protocol and ethical approval.
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Single arm. All the recruited preterm infants will undergo increasing and decreasing levels of PEEP and the effect of EIT with various PEEP levels will be studied.
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|
| Total study time of 280 minutes |
| Secondary outcome | Changes in fraction of inspiratory oxygen (Fio2) levels during the study. | Total study time of 280 minutes |
| Secondary outcome | Changes in blood pressure (if measured) during the study procedure. | Total study time of 280minutes |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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