Clinical trial NCT06705257: PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
Official title: EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PreTerm Neonate
Positive End Expiratory Pressure (PEEP)
Lung Recruitment
Electrical Impedance Tomography (EIT)
Keywords: positive end expiratory pressure
PRETERM
Electrical Impedance Tomography
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The James Cook University Hospital Marton Road Middlesbrough TS4 3BW
First posted: 2024-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm. All the recruited preterm infants will undergo increasing and decreasing levels of PEEP and the effect of EIT with various PEEP levels will be studied.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Changes in EIT parameters
timeFrame: total study of 280 minutes
measure: Changes in EIT parameters
timeFrame: 280minutes
measure: Changes in EIT
timeFrame: 280 minutes
Secondary outcomes:
measure: Secondary outcomes
timeFrame: Total 280 minutes of study time
measure: Secondary outcome measure
timeFrame: Total study time of 280 minutes
measure: Secondary outcome
timeFrame: Total study time of 280 minutes
measure: Secondary outcome
timeFrame: Total study time of 280minutes
Other outcomes:
Locations:
Study officials:
affiliation: South Tees NHS foundation trust
name: Jackie Mitchell
role: STUDY_DIRECTOR
References: