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Completed

NCT Number: NCT07632066

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

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.

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Key information

Conditions

Prematurity; Extreme Feeding Difficulties Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Unit, Hopital Croix Rousse

Lyon, 69004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedside Suckometer

Other

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.

Structured Oral Stimulation Protocol

Other

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.

Primary outcomes

  1. Feasibility of bedside suckometry (successful recordings rate)

    Time frame: 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 outcomes

  1. Suction burst frequency

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hôpital de la Croix-Rousse

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study title

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

Acronym: STIMPREM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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