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

Not Applicable

Terminated

• Conditions: Nose Deformities, Acquired
• Interventions: Device: Rhinometry

• Registration Number: NCT02815345
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2017-03
• Study Completion: 2018-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measure of the nasal cavity	Rhinometry	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.

Primary Outcome Measures

Name	Time	Method
Minimal cross sectional area measured by acoustic rhinometry	during the hospitalization of the infants, from birth to week 8	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.

Trial Locations

Locations (1)

CHI CRETEIL Neonatalogy; 🇫🇷 Creteil, France