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

June 2, 2026 updated by: Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse

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

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 GA) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 CNRS, 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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Neonatal Unit, Hopital Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Very preterm infants

Description

Inclusion Criteria:

  1. Gestational age at birth: 27+0 to 32+0 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NOSTIM group
Infants hospitalised before the implantation of Structured Oral Stimulation Protocol
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.
STIM group
Infants hospitalised after the implantation of Structured Oral Stimulation Protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital de la Croix-Rousse

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: jean-charles picaud, md, phd, Hopital croix rousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Hospices civils de Lyon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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