Intraoral Measurement of Pressure in Preterm Infants

Completed

• Conditions: Preterm Infants

• Registration Number: NCT04800198
• Lead Sponsor: University Medical Center Goettingen

Brief Summary

The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

Detailed Description

The aim of the investigation is to show the pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies, with a number large enough for an analysis. For this purpose, the pressure in the nasopharynx of these children is to be measured using a suction catheter, as is usually used to suction off mucus and saliva, and the measured values are to be evaluated with software. This method is a tried and tested method in adults for measuring the pressure conditions in the nasopharynx, which was developed and used by Mr. Olthoff. A possible later clinical application in premature and newborn infants ranges from the measurement of breathing and ventilation to manual control of respiratory support depending on the measured value to automatic triggering and control of a ventilator in the sense of nSIPPV ventilation (non-invasive synchronized intermittent positive pressure ventilation )

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

newborns, non-invasive ventilation

Exclusion Criteria

• Bad clinical condition of the patient (e.g. sepsis)
• Bleeding tendency
• Anatomical peculiarities that make it difficult to insert the suction catheter through the nose (e.g. choanal atresia)
• Lack of acceptance of the probe by the child
• Proven infection / colonization of the child by a multi-resistant germ (MRGN 2-4, MRSA) or with noro- / adenoviruses
• Missing / withdrawn consent by the legal guardians

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median Pressure reached by any tape of non-invasive ventilation	1 year	The pressure reached by non-invasive ventiation (nCPAP or HFT) in neonates of any gestation is measured weekly to collect data on how to correctly set the ventilator.

Trial Locations

Locations (1)

University Medicine Göttingen; 🇩🇪 Göttingen, Germany