Preterm InfantsNCT04800198
Intraoral Measurement of Pressure in Preterm Infants
An observational study of Preterm Infants, run by University Medical Center Goettingen at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 3 days to 3 months
- Conditions the study is for
- Preterm Infants
- What is being tested?
- non-invasive ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 3 months
- All sexes
- Child
Study population: newborns, in hospital
Who may be able to join
- newborns, non-invasive ventilation
Who cannot join
- 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- Missing / withdrawn consent by the legal guardians
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies
Read the 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 )
- Conditions
- Preterm Infants
- Being tested
- non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationProcedure or surgery
none, measurements only
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helmut Küster, University Medical Center Goettingen
- Investigators
- Helmut Küster, MD, Principal investigator, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800198
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoral Measurement of Pressure in Preterm Infants
- ClinicalTrials.gov ID
- NCT04800198
- Acronym / sponsor ID
- 1
- Conditions
- Preterm Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 3 months
- Sex
- All
- Age groups
- Child
- Study population
- newborns, in hospital
Key inclusion criteria (1 listed)
- newborns, non-invasive ventilation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ventilationnone, measurements only | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Küster, MD principal investigator
University Medical Center Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Pressure reached by any tape of non-invasive ventilation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.