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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Changes of heart rate between baseline, a semi-upright car seat position, and a follow-up supine position. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Bassler, Prof. | Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| D000091642 | Urogenital Diseases |