Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats

NCT ID: NCT06724601

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2025-08-22

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Electrical Impedance Tomography

Intervention Type: 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.

Interventions

Electrical Impedance Tomography

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Bassler, Prof.

Role: STUDY_CHAIR

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

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

CarSeat

Identifier Type: -

Identifier Source: org_study_id