PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
[PEOPLE]
EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedStudy Start
First participant enrolled
June 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 6, 2026
May 1, 2025
1 year
November 19, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (4)
Secondary outcomes
Total 280 minutes of study time
Secondary outcome measure
Total study time of 280 minutes
Secondary outcome
Total study time of 280 minutes
Secondary outcome
Total study time of 280minutes
Study Arms (1)
Single arm with increasing and decreasing PEEP levels
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Gestational age \<32 weeks based on mother's last menstrual period or first trimester ultrasound dating.
- Receiving either CPAP or mechanical ventilation respiratory support.
- Informed written consent from one of the parents.
- Within the first two weeks of life. Investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. Also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life.
You may not qualify if:
- Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.
- Infants diagnosed with pneumothorax i.
- Receiving high frequency mechanical ventilation.
- Infants with concerns of skin integrity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Tees NHS Trust
Middlesbrough, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jackie Mitchell
South Tees NHS foundation trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2024
First Posted
November 26, 2024
Study Start
June 15, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 6, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After the main study publication
- Access Criteria
- With valid study protocol and ethical approval.