Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats

NCT06724601 | Completed

• 1 other identifier: CarSeat
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Birth; Electrical Impedance Tomography (EIT); Lung Volume; Car Seat Transition for At-risk Infants

Keywords

electrical impedance tomography; premature birth; car seat

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  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

  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.

Study Arms (1)

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.

Device: Electrical Impedance Tomography

Interventions

Electrical Impedance Tomography DEVICE

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.

Preterm infants < 37 weeks gestation at birth or birthweight <2.5 kg (within 48 hours of discharge)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dirk Bassler, Prof.

  Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 3, 2025
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)