- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07604818
Comparison of Sucking in Premature Infants and Infants With Pierre Robin Sequence (NUTROBIN)
Comparison of Sucking in Premature Infants and Infants With Pierre Robin Syndrome
The NUTROBIN study aims to analyze sucking in two populations of vulnerable children who require intensive and prolonged care, and whose treatment has an impact on the subsequent development of oral function. This development has a significant impact on the overall psychomotor development.
- Prematurity and oral function Very premature birth, before 29 weeks is associated with significant neonatal morbiditywhich interferes with the development of oral competencies. The coordination of sucking, swallowing, and breathing, which is necessary for oral feeding, commonly matures after 34 weeks postconceptional age (Quetin 2015). During the first weeks of life, the oral sphere of these babies is both under-stimulated due to the enteral feeding via a fed via a gastric tube, and negatively stimulated due to fixation of the tube on the perioral area together with regular necessary tube changes. The more premature an infant is, the more significant these disturbances are, delaying the acquisition of feeding autonomy (Lau 2020), which is essential for discharge from the hospital. Positive oral stimulation, such as non-nutritive sucking (pacifier), and perioral stimulation can support the development of oral feeding in these vulnerable infants. Many questions remain regarding the development of sucking in premature infants, as there are few tools available to analyse it accurately.
- NUTRIO study in premature infants This is a prospective, single-centre, RIPH 3 non-health product study. It was set up in the Croix Rousse neonatal unit, in collaboration with Prof. Luc Marlier, CNRS Strasbourg, who developed a succiometre. The objective is to measure sucking parameters and describe their evolution in a population of extremely premature infants whose daily care includes an oral stimulation program. Enrolment in the NUTRIO study began in January 2025 and is currently ongoing. Ten infants have been enrolled, and a total of 30 are expected to be included.
- The DYSROBIN study in infants with Pierre Robin sequence This is a prospective, multicentre study that aimed to evaluate the involvement of brainstem dysfunction in the pathophysiology of Pierre Robin sequence. To assess brainstem dysfunction, several tests were performed to collect the various elements that make up the spectrum of dysautonomia: central sleep apnoea (nighttime polysomnography), cardiac variability abnormalities (24-hour Holter ECG), gastroesophageal reflux (pH monitoring, impedance measurement), sucking difficulties (sucking measurement). A group of infants with Pierre Robin sequence (upper airway obstruction, suspected brainstem involvement) was compared to a group of infants with isolated airway obstruction (laryngomalacia, choanal atresia, etc.) and healthy infants. Inclusions were completed in 2022 and included 53 infants with Pierre Robin sequence. Two ancillary publications have been produced, one submission is imminent, and the main study is currently being written.
Justification for the NUTROBIN study:
This study will help to better define the sucking profile of infants with Pierre Robin sequence in order to determine the actions to be taken to support oral function in these infants from the first weeks of life and limit the neurodevelopmental consequences and the impact on the quality of life of the infant and their family caused by oral function disorders.
The public interest of the study lies in the fact that it will clarify the specificities of the sucking and swallowing profile of infants with Pierre Robin sequence, enable families to be better informed about these children's oral disorders, and thus offer targeted, personalized multidisciplinary care (paediatrician, speech therapist, dietitian).
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Rhone
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Lyon, Rhone, Francia, 69004
- Hôpital Croix Rousse
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients included in the DYSROBIN study who underwent succiometry or
- Patients included in the NUTRIO study
Exclusion Criteria:
- Opposition by legal representatives
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Children with Pierre Robin syndrome
Children with Pierre Robin syndrome included in the DYSROBIN study who underwent succiometry as part of the study.
|
Comparison of data measured by succiometry between children with Pierre Robin syndrome (DYSROBIN; closed) and very premature infants (NUTRIO; ongoing).
|
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Extremely premature infants
Extremely pemature infants included in the NUTRIO study who underwent succiometry as part of the study.
|
Comparison of data measured by succiometry between children with Pierre Robin syndrome (DYSROBIN; closed) and very premature infants (NUTRIO; ongoing).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of suction and crushing peaks
Lasso di tempo: between 33 and 36 weeks postconceptional age
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The primary endpoint is the number of suction and crushing peaks
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between 33 and 36 weeks postconceptional age
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie muscoloscheletriche
- Malattie stomatognatiche
- Disordini mentali
- Malattie urogenitali femminili e complicanze della gravidanza
- Segni e sintomi, Digestivo
- Malattie della mascella
- Travaglio ostetrico, prematuro
- Complicanze ostetriche del lavoro
- Complicazioni della gravidanza
- Anomalie della mascella
- Anomalie maxillo-facciali
- Anomalie craniofacciali
- Anomalie muscoloscheletriche
- Anomalie del sistema stomatognatico
- Anomalie congenite
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Nascita prematura
- Disturbi dell'alimentazione e dell'alimentazione
- Sindrome di Pierre-Robin
Altri numeri di identificazione dello studio
- 25-5295
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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