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NCT Number: NCT06705257

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT 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.

Recruiting

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Key information

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Tees NHS Trust

Middlesbrough, United Kingdom

Location status: Recruiting

Location contact

Prakash Logananthan

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in EIT parameters

    Time frame: total study of 280 minutes

    Changes in End expiratory Lung Impedance scores

  2. Changes in EIT parameters

    Time frame: 280minutes

    Changes in functional lung scores in percentage varying levels of CDP.

  3. Changes in EIT

    Time frame: 280 minutes

    Changes in silence spaces with varying levels of CDP.

Secondary outcomes

  1. Secondary outcomes

    Time frame: Total 280 minutes of study time

    Changes in oxygen saturation (SpO2 in percentage) during the study period.

  2. Secondary outcome measure

    Time frame: Total study time of 280 minutes

    Changes in carbon dioxide levels as measured by transcutaneous carbon dioxide levels (TCO2) in kilopascal.

  3. Secondary outcome

    Time frame: Total study time of 280 minutes

    Changes in fraction of inspiratory oxygen (Fio2) levels during the study.

  4. Secondary outcome

    Time frame: Total study time of 280minutes

    Changes in blood pressure (if measured) during the study procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Forster

CONTACT

[email protected]

+44 1642 854872

Prakash Kannan Loganathan, MD

CONTACT

[email protected]

+447481492632

Sponsors and collaborators

Lead sponsor

South Tees Hospitals NHS Foundation Trust

Other

Registry information

Official study title

EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY

Acronym: [PEOPLE]

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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