Intraoral Measurement of Pressure in Preterm Infants

Preterm Infants Clinical Trial

Official title:

Intraoral Measurement of Pressure in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800198
• Other study ID #: 1
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 3 Days to 3 Months

Eligibility

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• Missing / withdrawn consent by the legal guardians

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Procedure:
• non-invasive ventilation
none, measurements only

Locations

Country	Name	City	State
Germany	University Medicine Göttingen	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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