NCT02815345

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

Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-03-01
• Completion: 2018-12-01
• First posted: 2016-06-28
• Last updated: 2023-02-10

Locations

1 site across 1 country: France