PreTerm Neonate[PEOPLE]NCT06705257
PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
A study testing Studying the effects of varying levels of PEEP using Electrical impedance tomography in people with PreTerm Neonate and Positive End Expiratory Pressure (PEEP), run by South Tees Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment
- What is being tested?
- Studying the effects of varying levels of PEEP using Electrical impedance tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
South Tees NHS Trust
Middlesbrough
Prakash Logananthan, pkannanloganathan@nhs.net
About this study
Official title: EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY 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.
- Conditions
- PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment, Electrical Impedance Tomography (EIT)
- Being tested
- Studying the effects of varying levels of PEEP using Electrical impedance tomography
- Keywords
- positive end expiratory pressure, PRETERM, Electrical Impedance Tomography
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Studying the effects of varying levels of PEEP using Electrical impedance tomographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm with increasing and decreasing PEEP levels | Experimental | Not described Receives: Diagnostic Test: Studying the effects of varying levels of PEEP using Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EIT parameters
Changes in End expiratory Lung Impedance scores
Measured: total study of 280 minutes
Changes in EIT parameters
Changes in functional lung scores in percentage varying levels of CDP.
Measured: 280minutes
Changes in EIT
Changes in silence spaces with varying levels of CDP.
Measured: 280 minutes
Secondary outcomes (4)
Secondary outcomes
Changes in oxygen saturation (SpO2 in percentage) during the study period.
Measured: Total 280 minutes of study time
Secondary outcome measure
Changes in carbon dioxide levels as measured by transcutaneous carbon dioxide levels (TCO2) in kilopascal.
Measured: Total study time of 280 minutes
Secondary outcome
Changes in fraction of inspiratory oxygen (Fio2) levels during the study.
Measured: Total study time of 280 minutes
Secondary outcome
Changes in blood pressure (if measured) during the study procedure.
Measured: Total study time of 280minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm NeonateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackie Mitchell, Study director, South Tees NHS foundation trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705257
- Sponsor's protocol ID
- IRAS [340081] - [PEOPLE]
- Acronym
- [PEOPLE]
- Status last verified
- May 2025
- First submitted
- 19 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT06705257
- Acronym / sponsor ID
- [PEOPLE] / IRAS [340081] - [PEOPLE]
- Conditions
- PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment, Electrical Impedance Tomography (EIT)
- Keywords
- positive end expiratory pressure, PRETERM, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm with increasing and decreasing PEEP levels | Experimental | Diagnostic Test: Studying the effects of varying levels of PEEP using Electrical impedance tomography |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Studying the effects of varying levels of PEEP using Electrical impedance tomographyFeasibility 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. | Diagnostic test | Single arm with increasing and decreasing PEEP levels |
Primary outcome
Changes in EIT parameters
Time frame: total study of 280 minutes
Changes in End expiratory Lung Impedance scores
Changes in EIT parameters
Time frame: 280minutes
Changes in functional lung scores in percentage varying levels of CDP.
Changes in EIT
Time frame: 280 minutes
Changes in silence spaces with varying levels of CDP.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for PreTerm Neonate
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Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jackie Mitchell study director
South Tees NHS foundation trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Studying the effects of varying levels of PEEP using Electrical impedance tomography in people with PreTerm Neonate and Positive End Expiratory Pressure (PEEP), run by South Tees Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prakash Kannan Loganathan, MD (+447481492632, pkannanloganathan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EIT parameters (time frame: total study of 280 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.