Comparison of Sucking in Premature Infants and Infants With Pierre Robin Sequence

NCT07604818 | Completed

• 1 other identifier: 25-5295
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The NUTROBIN study aims to analyze sucking in two populations of vulnerable children who require intensive and prolonged care, and whose treatment has an impact on the subsequent development of oral function. This development has a significant impact on the overall psychomotor development.

• Prematurity and oral function Very premature birth, before 29 weeks is associated with significant neonatal morbiditywhich interferes with the development of oral competencies. The coordination of sucking, swallowing, and breathing, which is necessary for oral feeding, commonly matures after 34 weeks postconceptional age (Quetin 2015). During the first weeks of life, the oral sphere of these babies is both under-stimulated due to the enteral feeding via a fed via a gastric tube, and negatively stimulated due to fixation of the tube on the perioral area together with regular necessary tube changes. The more premature an infant is, the more significant these disturbances are, delaying the acquisition of feeding autonomy (Lau 2020), which is essential for discharge from the hospital. Positive oral stimulation, such as non-nutritive sucking (pacifier), and perioral stimulation can support the development of oral feeding in these vulnerable infants. Many questions remain regarding the development of sucking in premature infants, as there are few tools available to analyse it accurately.
• NUTRIO study in premature infants This is a prospective, single-centre, RIPH 3 non-health product study. It was set up in the Croix Rousse neonatal unit, in collaboration with Prof. Luc Marlier, CNRS Strasbourg, who developed a succiometre. The objective is to measure sucking parameters and describe their evolution in a population of extremely premature infants whose daily care includes an oral stimulation program. Enrolment in the NUTRIO study began in January 2025 and is currently ongoing. Ten infants have been enrolled, and a total of 30 are expected to be included.
• The DYSROBIN study in infants with Pierre Robin sequence This is a prospective, multicentre study that aimed to evaluate the involvement of brainstem dysfunction in the pathophysiology of Pierre Robin sequence. To assess brainstem dysfunction, several tests were performed to collect the various elements that make up the spectrum of dysautonomia: central sleep apnoea (nighttime polysomnography), cardiac variability abnormalities (24-hour Holter ECG), gastroesophageal reflux (pH monitoring, impedance measurement), sucking difficulties (sucking measurement). A group of infants with Pierre Robin sequence (upper airway obstruction, suspected brainstem involvement) was compared to a group of infants with isolated airway obstruction (laryngomalacia, choanal atresia, etc.) and healthy infants. Inclusions were completed in 2022 and included 53 infants with Pierre Robin sequence. Two ancillary publications have been produced, one submission is imminent, and the main study is currently being written. Justification for the NUTROBIN study: This study will help to better define the sucking profile of infants with Pierre Robin sequence in order to determine the actions to be taken to support oral function in these infants from the first weeks of life and limit the neurodevelopmental consequences and the impact on the quality of life of the infant and their family caused by oral function disorders. The public interest of the study lies in the fact that it will clarify the specificities of the sucking and swallowing profile of infants with Pierre Robin sequence, enable families to be better informed about these children's oral disorders, and thus offer targeted, personalized multidisciplinary care (paediatrician, speech therapist, dietitian).

Conditions

Premature Infants; Feeding Disorder; Pierre Robin Sequence

Keywords

Feeding; Orality; Prematurity

Outcome Measures

Primary Outcomes (1)

• Number of suction and crushing peaks

  The primary endpoint is the number of suction and crushing peaks

  between 33 and 36 weeks postconceptional age

Study Arms (2)

Children with Pierre Robin syndrome

Children with Pierre Robin syndrome included in the DYSROBIN study who underwent succiometry as part of the study.

Other: Succiometry

Extremely premature infants

Extremely pemature infants included in the NUTRIO study who underwent succiometry as part of the study.

Other: Succiometry

Interventions

Succiometry OTHER

Comparison of data measured by succiometry between children with Pierre Robin syndrome (DYSROBIN; closed) and very premature infants (NUTRIO; ongoing).

Children with Pierre Robin syndrome; Extremely premature infants

Eligibility Criteria

• Age: Up to 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in the NUTRIO or DYSROBIN studies with succiometry measurements.

You may qualify if:

• Patients included in the DYSROBIN study who underwent succiometry or
• Patients included in the NUTRIO study

You may not qualify if:

• Opposition by legal representatives

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Croix Rousse

Lyon, Rhone, 69004, France

Location

MeSH Terms

Conditions

Premature Birth; Pierre Robin Syndrome; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: January 9, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)