Intraoral Measurement of Pressure in Preterm Infants

November 28, 2023 updated by: Helmut Küster, University Medical Center Goettingen
The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37099
        • University Medicine Gottingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 3 months (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

newborns, in hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Investigators

  • Principal Investigator: Helmut Küster, MD, University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Infants

Clinical Trials on non-invasive ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe