Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study (STIMPREM)
Early Evolution of Oral Feeding Skills in Very Preterm Infants: Impact of an Oral Stimulation Program Assessed by Cot-side Suckometer
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination. This prospective pilot study have two aims: (1) to assess the feasibility of cot-side non-nutritive sucking assessment (suckometry) from the first postnatal days in very preterm infants; and (2) to characterise early sucking performances before and after routine implementation of a structured oral stimulation protocol.
Very preterm infants - born before 33 weeks gestational age - enrolled in a single-centre level III neonatal unit. Sucking performance measured weekly using a novel bedside suckometer from the first postnatal week until full oral feeding autonomy. Clinical outcomes and sucking parameters compared between non-stimulated (NOSTIM) and stimulated (STIM) groups.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The structured oral stimulation protocol was developed with reference to the Fucile protocol (Fucile et al., 2002) and the Premature Infant Oral Motor Intervention (PIOMI; Lessen et al., 2015). It involved gentle perioral stimulation using a gloved finger, progressing from the ear to the labial commissure. Responsive infants received escalating stimulation of the lips and intraoral structures (gums, palate, tongue). Sessions delivered 2-4 times daily by trained nurses during routine care, initiated within the first three postnatal days and continued until the introduction of oral feeding.
The suckometer (ICube Laboratory, UMR7357 Centre National Recherche Scientifique, Strasbourg) comprises a silicone teat connected to dual micro-pressure sensors quantifying suction (negative) and compression (positive) pressures in real time. Quantitative parameters include sucking peak frequency, compression peak frequency, and burst frequency.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Lyon, France, 69004
- Neonatal Unit, Hopital Croix Rousse
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Gestational age at birth: 27 to 32 weeks
- Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon
Exclusion Criteria:
- Ongoing sedation or analgesia
- Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
- Major congenital anomalies or chromosomal abnormalities
- Necrotising enterocolitis
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
NOSTIM group
Infants hospitalised before the implantation of Structured Oral Stimulation Protocol
|
Bedside non-nutritive suckometer comprising a silicone teat connected to dual micro-pressure sensors.
Quantifies suction (negative) and compression (positive) pressures in real time.
Measurements performed weekly from the first postnatal week until full oral feeding autonomy in all participants.
|
|
STIM group
Infants hospitalised after the implantation of Structured Oral Stimulation Protocol
|
Bedside non-nutritive suckometer comprising a silicone teat connected to dual micro-pressure sensors.
Quantifies suction (negative) and compression (positive) pressures in real time.
Measurements performed weekly from the first postnatal week until full oral feeding autonomy in all participants.
The structured oral stimulation protocol was developed with reference to the Fucile protocol (Fucile et al., 2002) and the Premature Infant Oral Motor Intervention (PIOMI; Lessen et al., 2015).
It involved gentle perioral stimulation using a gloved finger, progressing from the ear to the labial commissure.
Responsive infants received escalating stimulation of the lips and intraoral structures (gums, palate, tongue).
Sessions delivered 2-4 times daily by trained nurses during routine care, initiated within the first three postnatal days and continued until the introduction of oral feeding.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of bedside suckometry (successful recordings rate)
Délai: From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks
|
Proportion of infants with successful suckometry recordings from the first postnatal week.
Feasibility defined as absence of adverse events and completion of weekly assessments.
|
From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Suction burst frequency
Délai: Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks
|
Number of suction bursts per session compared between STIM and NOSTIM groups over time
|
Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: jean-charles picaud, md, phd, Hopital croix rousse
Publications et liens utiles
Publications générales
- Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5.
- Lau C. Development of infant oral feeding skills: what do we know? Am J Clin Nutr. 2016 Feb;103(2):616S-21S. doi: 10.3945/ajcn.115.109603. Epub 2016 Jan 20.
- Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
- Lessen BS, Morello CA, Williams LJ. Establishing Intervention Fidelity of an Oral Motor Intervention for Preterm Infants. Neonatal Netw. 2015;34(2):72-82. doi: 10.1891/0730-0832.34.2.72.
- Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Hospices civils de Lyon
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .