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

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.

Study Overview

• Status: Recruiting
• Conditions: PreTerm Neonate; Lung Recruitment; Positive End Expiratory Pressure (PEEP); Electrical Impedance Tomography (EIT)
• Intervention / Treatment: Diagnostic test: Studying the effects of varying levels of PEEP using Electrical impedance tomography

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prakash Kannan Loganathan, MD; Phone Number: +447481492632; Email: pkannanloganathan@nhs.net
• Study Contact Backup: Name: Amanda Forster; Phone Number: +44 1642 854872; Email: amanda.forster2@nhs.net

Study Locations

• United Kingdom
  • Middlesbrough, United Kingdom
    • Recruiting
    • South Tees NHS Trust
    • Contact: Prakash Logananthan; Email: pkannanloganathan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Gestational age <32 weeks based on mother's last menstrual period or first trimester ultrasound dating.
2. Receiving either CPAP or mechanical ventilation respiratory support.
3. Informed written consent from one of the parents.
4. 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.

Exclusion criteria

1. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.
2. Infants diagnosed with pneumothorax i.
3. Receiving high frequency mechanical ventilation.
4. Infants with concerns of skin integrity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm with increasing and decreasing PEEP levels

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: South Tees Hospitals NHS Foundation Trust
• Collaborators: The James Cook University Hospital Marton Road Middlesbrough TS4 3BW
• Investigators: Study Director: Jackie Mitchell, South Tees NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography; positive end expiratory pressure; PRETERM
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: IRAS [340081] - [PEOPLE]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After the main study publication
• IPD Sharing Access Criteria: With valid study protocol and ethical approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes