Objectives and Measures Dimensions Nasal Resistance of Preterm and Term (MODERN)

NCT02815345 | Terminated

• 1 other identifier: CHIC MODERN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age \<30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . In the same study, the median number of attempts before achieving a final withdrawal was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and little studied. It seems that the type of interface used, mask or cannula, having an influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by non-invasive ventilation are not uncommon, regardless of the interface used . In a recent randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and non-invasive ventilation mode. It is in this case external damage. But we assume that the breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors are likely to generate a nasal obstruction, source intervention nurses who aspire nasal passages more or less traumatic. The nasal cavities are often abused and, because of their key role in breathing, could be involved in the withdrawal of ventilatory failure

Conditions

Nose Deformities, Acquired

Outcome Measures

Primary Outcomes (1)

• Minimal cross sectional area measured by acoustic rhinometry

  Acoustic rhinometry is a functional non-invasive procedure based on the sound reflection of acoustic waves on the nasal cavities. This procedure allows determining the geometry and the size of nasal cavities. The device is composed by a wave tube connected to a sound generator emitting series of acoustic impulsions. On this wave tube are laterally connected 2 microphones, themselves connected with a computer which analyzes the acoustic signal. These microphones detect the acoustic reflected wave.

  during the hospitalization of the infants, from birth to week 8

Study Arms (1)

Measure of the nasal cavity

EXPERIMENTAL

The nasal cavity of all the included neonates will be measured using rhinometry during their hospitalization every weeks. So one to 8 measurement will be performed for each neonates. Some included neonates will also have rhinomanometry measurements.

Device: Rhinometry

Interventions

Rhinometry DEVICE

An acoustic rhinometry device will be used to evaluate the area and the volume of the nasal cavities. Both nasal cavities will be measured except for patients with nasogastric tube.

Measure of the nasal cavity

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Affiliation to social security
• Informed Parental Consent
• Newborns term and preterm
• Age less than or equal to 28 days
• Signature of informed consent by both parents

You may not qualify if:

• craniofacial malformation
• Dyspnea (Silverman score\> 3)
• severe sepsis
• life-threatened

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI CRETEIL Neonatalogy

Créteil, 94000, France

Location

MeSH Terms

Conditions

Nose Deformities, Acquired

Interventions

Rhinometry, Acoustic

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Claude CD DANAN, MD

  CHI Créteil Neonatalogy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 28, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)