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Completed
NCT07632066
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Conditions: Prematurity; Extreme, Feeding Difficulties
Sex: All
Ages: N/A – 6 Months
Healthy volunteers: No
Enrollment: 17
Sponsor: Hôpital de la Croix-Rousse
Location: Neonatal Unit, Hopital Croix Rousse Lyon
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07632066). StuddyBuddy aggregates publicly available trial information.