Intraoral Measurement of Pressure in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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 )

Conditions

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Preterm Infants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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non-invasive ventilation

none, measurements only

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

3 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Helmut Küster

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helmut Küster, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Goettingen

Locations

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University Medicine Göttingen

Göttingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id