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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Lyon, Frankrike, 69004
- Neonatal Unit, Hopital Croix Rousse
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of bedside suckometry (successful recordings rate)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Suction burst frequency
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: jean-charles picaud, md, phd, Hopital croix rousse
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Nøkkelord
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- Hospices civils de Lyon
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