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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02815345
Other study ID # CHIC MODERN
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date December 2018

Study information

Verified date February 2023
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date December 2018
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 28 Days
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHI CRETEIL Neonatalogy Creteil

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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