Actively Recruiting

Phase Not Applicable
Age: 22Weeks - 32Weeks
All Genders
NCT06705257

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

Led by South Tees Hospitals NHS Foundation Trust · Updated on 2026-05-06

30

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

Who Can Participate

Age: 22Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

South Tees NHS Trust

Middlesbrough, United Kingdom

Actively Recruiting

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Research Team

P

Prakash Kannan Loganathan, MD

CONTACT

A

Amanda Forster

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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