NCT04800198

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

March 3, 2021

Last Update Submit

November 28, 2023

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

non-invasive ventilationPROCEDURE

none, measurements only

Eligibility Criteria

Age3 Days - 3 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

newborns, in hospital

You may qualify if:

  • newborns, non-invasive ventilation

You may not qualify if:

  • 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  • Missing / withdrawn consent by the legal guardians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Göttingen

Göttingen, 37099, Germany

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Helmut Küster, MD

    University Medical Center Goettingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 16, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)