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

Study Overview

• Status: Completed
• Conditions: Preterm Infants
• Intervention / Treatment: Procedure: non-invasive ventilation

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

Study Locations

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

Participation Criteria

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• Missing / withdrawn consent by the legal guardians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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Pressure reached by any tape of non-invasive ventilation	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

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

Study record dates

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: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• 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