Premature BirthCarSeatNCT06724601
Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats
An observational study of Premature Birth and Electrical Impedance Tomography (EIT), run by University of Zurich at 1 site in Switzerland.
Trial summary
Premature infants (infants born <37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. The safe transport of these premature infants is an important concern. Sub-optimal positioning in car seats can lead to breathing problems in premature infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth, Electrical Impedance Tomography (EIT), Lung Volume
- What is being tested?
- Electrical Impedance Tomography
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jan 2025to 22 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will take place at the Department of Neonatology of the University Hospital Zurich. Preterm infants ready for discharge will be screened for eligibility and parents will be approached by the treating physician or a clinician-researcher who is authorized to access the patient's clinical data.
Who may be able to join
- Gestational age up to 36 6/7 weeks at birth and/or birthweight < 2.5 kg
- Preterm born infants fulfilling all criteria for discharge from the NICU
- Discharge home planned within 48 hours
- Written informed consent by one or both parents or legal guardians as documented by signature.
Who cannot join
- Severe malformation adversely affecting lung aeration or malformations limiting life expectancy.
- Inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats - A Prospective Observational Study
Premature infants (infants born <37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. The safe transport of these premature infants is an important concern. Sub-optimal positioning in car seats can lead to breathing problems in premature infants. With the help of electrical impedance tomography, the investigators want to assess the changes in lung volume during the transition from a supine to a semi-upright position in the car seat.
Read the detailed description
Hypothesis The investigators hypothesise that there is a decrease in the end-expiratory lung volume (EELV) of preterm infants transferred from supine to car seat position. They expect that the curved, semi-upright built of a standard car seat negatively impacts lung aeration and ventilation of preterm infants, which may result in cardiorespiratory events. They also hypothesise that EELV will normalise following the repositioning of the infant back to the supine position.
Primary objective The primary objective of this study is to assess lung volume changes during the transition from a supine to a semi-upright position in a car seat in preterm infants.
Study procedures As soon as all inclusion criteria are met, the study intervention is initiated. For the baseline measurement, the child is placed in supine position on a flat surface. The EIT belt is attached at nipple level around the infant's thorax during the last nursing care before the start of the intervention. Continuous measurement is conducted for 30 minutes.
Subsequently, the child, with the EIT belt securely in place, is repositioned from a supine to a semi-upright position in a car seat, where another 30-minute measurement is taken. A third measurement will be conducted after the infant is returned to the standard supine position in his/her cot. Manipulations during the measurement periods will be kept to a minimum to avoid disruptions or artefacts in the data recordings. EIT data will be obtained for a total of 90 minutes (plus a maximum of 10 minutes for repositioning).
Subgroup analyses will be performed for the primary outcome:
- Preterm infants ≥ 32 versus < 32 weeks at birth
- Infants with a weight ≥ 2 kg versus < 2 kg at the time of the study
- Car seat positioning: nursing staff versus parents
- Conditions
- Premature Birth, Electrical Impedance Tomography (EIT), Lung Volume, Car Seat Transition for At-risk Infants
- Being tested
- Electrical Impedance Tomography
- Keywords
- electrical impedance tomography, premature birth, car seat
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
Electrical Impedance Tomography data and the physiological and clinical parameters will be recorded continuously in three different positions (supine 1, car seat, supine 2) to assess alterations in lung volume and cardiorespiratory events.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants < 37 weeks gestation at birth or birthweight <2.5 kg (within 48 hours of discharge) | Preterm infants with gestational age up to 36 6/7 weeks at birth and/or birthweight < 2.5 kg will be included. They must fulfill all criteria for discharge from the Neonatal Intensive Care Unit and be discharged home within 48 hours at the time of measurement. Receives: Device: Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global end-expiratory lung impedance
Changes in global end-expiratory lung impedance (EELZ) between a baseline measurement in supine position, measurement in a semi-upright car seat position, and a follow-up measurement back in a supine position, as a measure of lung aeration and a proxy for end-expiratory lung volume (∆EELZ = EELZCarSeat - EELZBaseline).
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Secondary outcomes (15)
Heart rate
Changes of heart rate between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Number of bradycardia
Changes in the number of bradycardia (heart rate < 80 bpm) between a baseline measurement in supine position, measurement in a semi-upright car seat position, and a follow-up measurement back in a supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Respiratory rate
Changes in respiratory rate between baseline, a semi-upright car seat position, and a follow-up supine position based on EIT data.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Oxygen Saturation
Changes in oxygen saturation between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Number of desaturations
Changes in the number of desaturations (SpO2 < 80%) between a baseline measurement in supine position, measurement in a semi-upright car seat position, and a follow-up measurement back in a supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Regional end-expiratory lung impedance
Changes in regional end-expiratory lung impedance between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Tidal Volume
Changes in tidal volume using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Respiratory minute volume
Changes in respiratory minute volume using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Regional tidal volume distribution
Changes in regional tidal distribution using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Silent spaces, depenent
Changes in dependent silent spaces using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Silent spaces, nondependent
Changes in nondependent silent spaces using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Center of ventilation, ventral to dorsal
Changes in center of ventilation (ventral to dorsal) using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Center of ventilation, left to right
Changes in center of ventilation (left to right) using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Global inhomogeneity index
Changes in global inhomogeneity index using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Coefficient of variation
Changes in coefficient of variation using EIT between baseline, a semi-upright car seat position, and a follow-up supine position.
Measured: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start3 Jan 2025
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Bassler, Prof., Study chair, Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724601
- Sponsor's protocol ID
- CarSeat
- Acronym
- CarSeat
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06724601
- Acronym / sponsor ID
- CarSeat / CarSeat
- Conditions
- Premature Birth, Electrical Impedance Tomography (EIT), Lung Volume, Car Seat Transition for At-risk Infants
- Keywords
- electrical impedance tomography, premature birth, car seat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 9 Dec 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.
Premature infants (infants born <37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. The safe transport of these premature infants is an important concern. Sub-optimal positioning in car seats can lead to breathing problems in premature infants. With the help of electrical impedance tomography, the investigators want to assess the changes in lung volume during the transition from a supine to a semi-upright position in the car seat.
Detailed description
Hypothesis The investigators hypothesise that there is a decrease in the end-expiratory lung volume (EELV) of preterm infants transferred from supine to car seat position. They expect that the curved, semi-upright built of a standard car seat negatively impacts lung aeration and ventilation of preterm infants, which may result in cardiorespiratory events. They also hypothesise that EELV will normalise following the repositioning of the infant back to the supine position.
Primary objective The primary objective of this study is to assess lung volume changes during the transition from a supine to a semi-upright position in a car seat in preterm infants.
Study procedures As soon as all inclusion criteria are met, the study intervention is initiated. For the baseline measurement, the child is placed in supine position on a flat surface. The EIT belt is attached at nipple level around the infant's thorax during the last nursing care before the start of the intervention. Continuous measurement is conducted for 30 minutes.
Subsequently, the child, with the EIT belt securely in place, is repositioned from a supine to a semi-upright position in a car seat, where another 30-minute measurement is taken. A third measurement will be conducted after the infant is returned to the standard supine position in his/her cot. Manipulations during the measurement periods will be kept to a minimum to avoid disruptions or artefacts in the data recordings. EIT data will be obtained for a total of 90 minutes (plus a maximum of 10 minutes for repositioning).
Subgroup analyses will be performed for the primary outcome:
- Preterm infants ≥ 32 versus < 32 weeks at birth
- Infants with a weight ≥ 2 kg versus < 2 kg at the time of the study
- Car seat positioning: nursing staff versus parents
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants < 37 weeks gestation at birth or birthweight <2.5 kg (within 48 hours of discharge) | – | Device: Electrical Impedance TomographyPreterm infants with gestational age up to 36 6/7 weeks at birth and/or birthweight < 2.5 kg will be included. They must fulfill all criteria for discharge from the Neonatal Intensive Care Unit and be discharged home within 48 hours at the time of measurement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will take place at the Department of Neonatology of the University Hospital Zurich. Preterm infants ready for discharge will be screened for eligibility and parents will be approached by the treating physician or a clinician-researcher who is authorized to access the patient's clinical data.
Key inclusion criteria (4 listed)
- Gestational age up to 36 6/7 weeks at birth and/or birthweight < 2.5 kg
- Preterm born infants fulfilling all criteria for discharge from the NICU
- Discharge home planned within 48 hours
- Written informed consent by one or both parents or legal guardians as documented by signature.
Key exclusion criteria (2 listed)
- Severe malformation adversely affecting lung aeration or malformations limiting life expectancy.
- Inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
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 |
|---|---|---|
| Electrical Impedance TomographyElectrical Impedance Tomography data and the physiological and clinical parameters will be recorded continuously in three different positions (supine 1, car seat, supine 2) to assess alterations in lung volume and cardiorespiratory events. | Device | Preterm infants < 37 weeks gestation at birth or birthweight <2.5 kg (within 48 hours of discharge) |
Primary outcome
Global end-expiratory lung impedance
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Changes in global end-expiratory lung impedance (EELZ) between a baseline measurement in supine position, measurement in a semi-upright car seat position, and a follow-up measurement back in a supine position, as a measure of lung aeration and a proxy for end-expiratory lung volume (∆EELZ = EELZCarSeat - EELZBaseline).
15 secondary outcomes
Heart rate
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Number of bradycardia
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Respiratory rate
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Oxygen Saturation
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Number of desaturations
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Regional end-expiratory lung impedance
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Tidal Volume
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Respiratory minute volume
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Regional tidal volume distribution
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Silent spaces, depenent
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Silent spaces, nondependent
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Center of ventilation, ventral to dorsal
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Center of ventilation, left to right
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Global inhomogeneity index
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Coefficient of variation
Time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dirk Bassler, Prof. study chair
Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Electrical Impedance Tomography (EIT), run by University of Zurich at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global end-expiratory lung impedance (time frame: Continuous measurement is conducted for 30 minutes in a supine position, 30 minutes in a semi-upright car seat position and an additional 30 minutes in a supine position. Total measurement of 90 minutes.). 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 22 Sep 2025.