- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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).
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Rhone
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Lyon, Rhone, Francie, 69004
- Hôpital Croix Rousse
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients included in the DYSROBIN study who underwent succiometry or
- Patients included in the NUTRIO study
Exclusion Criteria:
- Opposition by legal representatives
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Children with Pierre Robin syndrome
Children with Pierre Robin syndrome included in the DYSROBIN study who underwent succiometry as part of the study.
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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.
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Comparison of data measured by succiometry between children with Pierre Robin syndrome (DYSROBIN; closed) and very premature infants (NUTRIO; ongoing).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of suction and crushing peaks
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Nemoci pohybového aparátu
- Stomatognátní onemocnění
- Duševní poruchy
- Ženské urogenitální onemocnění a těhotenské komplikace
- Příznaky a symptomy, zažívací
- Onemocnění čelistí
- Porodnický porod, předčasný
- Porodnické porodní komplikace
- Těhotenské komplikace
- Abnormality čelistí
- Maxilofaciální abnormality
- Kraniofaciální abnormality
- Muskuloskeletální abnormality
- Abnormality stomatognátního systému
- Vrozené vady
- Vrozené, dědičné a neonatální nemoci a abnormality
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Předčasný porod
- Poruchy krmení a příjmu potravy
- Syndrom Pierra Robina
Další identifikační čísla studie
- 25-5295
Informace o lécích a zařízeních, studijní dokumenty
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