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Clinical Trials/NCT04800198
NCT04800198
Completed
Not Applicable

Intraoral Measurement of Pressure in Preterm Infants

University Medical Center Goettingen1 site in 1 country24 target enrollmentJanuary 1, 2021
ConditionsPreterm Infants

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infants
Sponsor
University Medical Center Goettingen
Enrollment
24
Locations
1
Primary Endpoint
Median Pressure reached by any tape of non-invasive ventilation
Status
Completed
Last Updated
2 years ago

Overview

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 )

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medical Center Goettingen
Responsible Party
Principal Investigator
Principal Investigator

Helmut Küster

MD, Principal Investigator

University Medical Center Goettingen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Median Pressure reached by any tape of non-invasive ventilation

Time Frame: 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.

Study Sites (1)

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