PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

NCT ID: NCT06705257

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-12-31

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.

Conditions

PreTerm Neonate; Positive End Expiratory Pressure (PEEP); Lung Recruitment; Electrical Impedance Tomography (EIT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm with increasing and decreasing PEEP levels

Group Type: EXPERIMENTAL

Studying the effects of varying levels of PEEP using Electrical impedance tomography

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The James Cook University Hospital Marton Road Middlesbrough TS4 3BW

UNKNOWN

Sponsor Role: collaborator

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jackie Mitchell

Role: STUDY_DIRECTOR

South Tees NHS foundation trust

Central Contacts

Prakash Kannan Loganathan, MD

Role: CONTACT

pkannanloganathan@nhs.net

+447481492632

Amanda Forster

Role: CONTACT

amanda.forster2@nhs.net

+44 1642 854872

Other Identifiers

IRAS [340081] - [PEOPLE]

Identifier Type: -

Identifier Source: org_study_id