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CompletedNCT07604818NUTROBINUpdated May 22, 2026

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

An observational study in Premature Infants, Pierre Robin Sequence and Feeding Disorder, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged Up to 29 Weeks. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
26
Ages
Up to 29 Weeks
Sex
All
01

Study 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).

02

Conditions studied

  • Premature Infants
  • Pierre Robin Sequence
  • Feeding Disorder

Keywords

  • Feeding
  • Orality
  • Prematurity
03

Who can participate

Ages eligible
Up to 29 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Opposition by legal representatives
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSucciometry

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

05

What researchers measure

Primary outcomes

  1. Number of suction and crushing peaks

    The primary endpoint is the number of suction and crushing peaks

    Time frame: between 33 and 36 weeks postconceptional age

06

Study locations

1 site
  • Hôpital Croix Rousse
    Lyon, Rhone 69004, France
07

Registry details

Key details

Study ID
NCT07604818
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Jan 9, 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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