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NCT07632066

Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study

Sponsor: Hôpital de la Croix-Rousse

View on ClinicalTrials.gov

Summary

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.

Official title: Early Evolution of Oral Feeding Skills in Very Preterm Infants: Impact of an Oral Stimulation Program Assessed by Cot-side Suckometer

Key Details

Gender

All

Age Range

Any - 6 Months

Study Type

OBSERVATIONAL

Enrollment

17

Start Date

2012-05-30

Completion Date

2013-05-01

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

OTHER

Bedside Suckometer

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.

OTHER

Structured Oral Stimulation Protocol

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.

Locations (1)

Neonatal Unit, Hopital Croix Rousse

Lyon, France