PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Studying the effects of varying levels of PEEP using Electrical impedance tomography.
- Who it may be relevant to
- Registry conditions: PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment, Electrical Impedance Tomography (EIT). Basic parameters: 22 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in EIT parameters [Time frame: total study of 280 minutes]
- Changes in EIT parameters [Time frame: 280minutes]
- Changes in EIT [Time frame: 280 minutes]
Secondary outcome measures (4)
- Secondary outcomes [Time frame: Total 280 minutes of study time]
- Secondary outcome measure [Time frame: Total study time of 280 minutes]
- Secondary outcome [Time frame: Total study time of 280 minutes]
- Secondary outcome [Time frame: Total study time of 280minutes]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- South Tees NHS Trust — Middlesbrough
Identifiers
NCT: NCT06705257 · IRAS [340081] - [PEOPLE]