Early Evolution of Oral Feeding Skills in Very Preterm Infants: Impact of an Oral Stimulation Program Assessed by Cot-side Suckometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth: 27 to 32 weeks
- •Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon
排除标准
- •Ongoing sedation or analgesia
- •Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
- •Major congenital anomalies or chromosomal abnormalities
- •Necrotising enterocolitis
研究组 & 干预措施
STIM group
Infants hospitalised after the implantation of Structured Oral Stimulation Protocol
干预措施: Bedside Suckometer (Other)
NOSTIM group
Infants hospitalised before the implantation of Structured Oral Stimulation Protocol
干预措施: Bedside Suckometer (Other)
STIM group
Infants hospitalised after the implantation of Structured Oral Stimulation Protocol
干预措施: Structured Oral Stimulation Protocol (Other)
研究者
Jean-charles PICAUD, MD, PhD
Professor of paediatrics
Hôpital de la Croix-Rousse