Nose Deformities, Acquired Clinical Trial
— MODERNOfficial title:
Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn
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 |
Verified date | February 2023 |
Source | Centre Hospitalier Intercommunal Creteil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | CHI CRETEIL Neonatalogy | Creteil |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil |
France,
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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