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

NCT ID: NCT02815345

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-12-31

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

Detailed Description

The measurements of the nasal cavity dimensions are carried out by acoustic rhinometry (about 10 seconds for an acquisition). Measurement of nasal resistance is performed by rhinomanometry earlier (about a minute to a measure). They may be made to wakefulness or sleep since they do not require their participation. These measures will be carried at birth and then every 7 to 10 days (before the age of 28 days), if the child is still hospitalized.

During these measurements, the heart rate and oxygen saturation are collected by a measuring sensor transcutaneously.

Conditions

Nose Deformities, Acquired

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Measure of the nasal cavity

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.

Group Type: EXPERIMENTAL

Rhinometry

Intervention Type: 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.

Interventions

Rhinometry

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• craniofacial malformation

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Claude Danan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claude CD DANAN, MD

Role: PRINCIPAL_INVESTIGATOR

CHI Créteil Neonatalogy

Locations

CHI CRETEIL Neonatalogy

Créteil, , France

Countries

France

Other Identifiers

CHIC MODERN

Identifier Type: -

Identifier Source: org_study_id