Clinical trial NCT02815345: Objectives and Measures Dimensions Nasal Resistance of Preterm and Term (MODERN)
Official title: Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nose Deformities, Acquired
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Minimal cross sectional area measured by acoustic rhinometry
timeFrame: during the hospitalization of the infants, from birth to week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHI CRETEIL Neonatalogy
Study officials:
affiliation: CHI Créteil Neonatalogy
name: Claude CD DANAN, MD
role: PRINCIPAL_INVESTIGATOR
References: