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

NCT07632066 | Completed

• 1 other identifier: Hospices civils de Lyon
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Extreme; Feeding Difficulties

Keywords

prematurity; oral stimulation; non nutritive sucking

Outcome Measures

Primary Outcomes (1)

• 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.

  From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks

Secondary Outcomes (1)

• Suction burst frequency

  Weekly from first postnatal week to full oral feeding autonomy, up to 7 weeks

Study Arms (2)

NOSTIM group

Infants hospitalised before the implantation of Structured Oral Stimulation Protocol

Other: Bedside Suckometer

STIM group

Infants hospitalised after the implantation of Structured Oral Stimulation Protocol

Other: Bedside Suckometer; Other: Structured Oral Stimulation Protocol

Interventions

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.

NOSTIM group; STIM group

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.

STIM group

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Very preterm infants

You may qualify if:

• Gestational age at birth: 27 to 32 weeks
• Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon

You may not qualify if:

• Ongoing sedation or analgesia
• Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
• Major congenital anomalies or chromosomal abnormalities
• Necrotising enterocolitis

Sponsors & Collaborators

• Hôpital de la Croix-Rousse: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Neonatal Unit, Hopital Croix Rousse

Lyon, 69004, France

Location

Related Publications (5)

• 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.

  PMID: 38626172 BACKGROUND

• Lau 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.

  PMID: 26791183 BACKGROUND

• Lau 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.

  PMID: 21212698 BACKGROUND

• Lessen 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.

  PMID: 26803089 BACKGROUND

• Fucile 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.

  PMID: 12183719 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• jean-charles picaud, md, phd

  Hopital croix rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of paediatrics

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: May 30, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

FR (1)