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Completed

NCT Number: NCT04800198

Intraoral Measurement of Pressure in Preterm Infants

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

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Key information

Conditions

Age range

3 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Göttingen

Göttingen, 37099, Germany

About this study

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 )

Who can participate

Only the study team can determine whether someone qualifies for participation.

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  • Missing / withdrawn consent by the legal guardians

Treatment and study plan

Non-invasive ventilation

Procedure

none, measurements only

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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