Prematurity; ExtremeSTIMPREMNCT07632066
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
An observational study of Prematurity; Extreme and Feeding Difficulties, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Prematurity; Extreme, Feeding Difficulties
- What is being tested?
- Bedside Suckometer and Structured Oral Stimulation Protocol
- Type of treatment
- Pill or oral medicine
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2012to 1 May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Very preterm infants
Who may be able to join
- Gestational age at birth: 27 to 32 weeks
- Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon
Who cannot join
- Ongoing sedation or analgesia
- Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
- Major congenital anomalies or chromosomal abnormalities
- Necrotising enterocolitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Prematurity; Extreme, Feeding Difficulties
- Being tested
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Keywords
- prematurity, oral stimulation, non nutritive sucking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside SuckometerOther
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NOSTIM group | Infants hospitalised before the implantation of Structured Oral Stimulation Protocol Receives: Other: Bedside Suckometer | |
| STIM group | Infants hospitalised after the implantation of Structured Oral Stimulation Protocol Receives: Other: Bedside Suckometer; Other: Structured Oral Stimulation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of bedside suckometry (successful recordings rate)
Proportion of infants with successful suckometry recordings from the first postnatal week. Feasibility defined as absence of adverse events and completion of weekly assessments.
Measured: From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks
Secondary outcomes (1)
Suction burst frequency
Number of suction bursts per session compared between STIM and NOSTIM groups over time
Measured: Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start30 May 2012
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Principal investigator, Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse
- Investigators
- jean-charles picaud, md, phd, Principal investigator, Hopital croix rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632066
- Sponsor's protocol ID
- Hospices civils de Lyon
- Acronym
- STIMPREM
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
PubMed 38626172Lau C. Development of infant oral feeding skills: what do we know? Am J Clin Nutr. 2016 Feb;103(2):616S-21S. doi: 10.3945/ajcn.115.109603. Epub 2016 Jan 20.
PubMed 26791183Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5.
PubMed 21212698Lessen BS, Morello CA, Williams LJ. Establishing Intervention Fidelity of an Oral Motor Intervention for Preterm Infants. Neonatal Netw. 2015;34(2):72-82. doi: 10.1891/0730-0832.34.2.72.
PubMed 26803089Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
PubMed 12183719Picaud JC, Pradat P, Pebayle T, Mory-Thomas N, Pastor-Diez B, Valette S, Marlier L. Early evolution of oral feeding skills in very preterm infants: impact of an oral stimulation protocol assessed by cot-side suckometer: a pilot study. Eur J Pediatr. 2026 Aug 20;185(9):680. doi: 10.1007/s00431-026-07344-0.
PubMed 42622905
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Evolution of Oral Feeding Skills in Very Preterm Infants: Impact of an Oral Stimulation Program Assessed by Cot-side Suckometer
- ClinicalTrials.gov ID
- NCT07632066
- Acronym / sponsor ID
- STIMPREM / Hospices civils de Lyon
- Conditions
- Prematurity; Extreme, Feeding Difficulties
- Keywords
- prematurity, oral stimulation, non nutritive sucking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 30 May 2012 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOSTIM group | – | Other: Bedside SuckometerInfants hospitalised before the implantation of Structured Oral Stimulation Protocol |
| STIM group | – | Other: Bedside Suckometer, Other: Structured Oral Stimulation ProtocolInfants hospitalised after the implantation of Structured Oral Stimulation Protocol |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very preterm infants
Key inclusion criteria (2 listed)
- Gestational age at birth: 27 to 32 weeks
- Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon
Key exclusion criteria (4 listed)
- Ongoing sedation or analgesia
- Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
- Major congenital anomalies or chromosomal abnormalities
- Necrotising enterocolitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside SuckometerBedside 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 | NOSTIM group, STIM group |
| Structured Oral Stimulation ProtocolThe 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. | Other | STIM group |
Primary outcome
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.
1 secondary outcome
Suction burst frequency
Time frame: Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 38626172Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
- Background: PubMed 26791183Lau C. Development of infant oral feeding skills: what do we know? Am J Clin Nutr. 2016 Feb;103(2):616S-21S. doi: 10.3945/ajcn.115.109603. Epub 2016 Jan 20.
- Background: PubMed 21212698Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5.
- Background: PubMed 26803089Lessen BS, Morello CA, Williams LJ. Establishing Intervention Fidelity of an Oral Motor Intervention for Preterm Infants. Neonatal Netw. 2015;34(2):72-82. doi: 10.1891/0730-0832.34.2.72.
- Background: PubMed 12183719Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
- Derived from this study: PubMed 42622905Picaud JC, Pradat P, Pebayle T, Mory-Thomas N, Pastor-Diez B, Valette S, Marlier L. Early evolution of oral feeding skills in very preterm infants: impact of an oral stimulation protocol assessed by cot-side suckometer: a pilot study. Eur J Pediatr. 2026 Aug 20;185(9):680. doi: 10.1007/s00431-026-07344-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean-charles picaud, md, phd principal investigator
Hopital croix rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity; Extreme and Feeding Difficulties, run by Hôpital de la Croix-Rousse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of bedside suckometry (successful recordings rate) (time frame: From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07632066, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.