Feeding Difficulties, Prematurity; Extreme
Conditions
Keywords
prematurity, oral stimulation, non nutritive sucking
Brief 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.
Detailed description
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.
Interventions
OTHERBedside 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.
OTHERStructured 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.
Sponsors
Hôpital de la Croix-Rousse
Centre National de la Recherche Scientifique, France
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Gestational age at birth: 27 to 32 weeks 2. Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon
Exclusion criteria
1. Ongoing sedation or analgesia 2. Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia 3. Major congenital anomalies or chromosomal abnormalities 4. Necrotising enterocolitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of bedside suckometry (successful recordings rate) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suction burst frequency | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORjean-charles picaud, md, phd
Hopital croix rousse
Outcome results
None listed