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RecruitingNCT06648083ORAPREMUpdated Oct 18, 2024

Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants

An observational study in Oral Disorders, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged Up to 28 Weeks. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
170
Ages
Up to 28 Weeks
Sex
All
01

Study summary

Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain, noise, and light), which can have a negative impact on their development. And more specifically on the development of oral skills. In the past decades, the standard of care has evolved and is based on less "aggressive" care and the implication of parents as caregivers. Recent data on the incidence of oral disorders in extremely premature babies are not currently available.

These oral disorders have significant short-term and long-term consequences. During hospitalization, it leads to a delay in the acquisition of full oral feeding, which is defined as the absence of need for tube feeding, and is associated with prolonged hospitalization. It is also associated with a delayed development of orality, which is essential for the proper psychomotor, and cognitive development of premature infants.

Strategies have been proposed to support the acquisition of oral feeding autonomy and to prevent oral feeding disorders, including tactile stimulation of orality consisting in stroking cheeks, peri-oral and intra-oral structures, but there is still no consensus on the best way to support the development of orality in this population.

In this context, a tactile stimulation protocol of orality, has been implemented in the past years, in the neonatal unit of the croix-rousse hospital, based on data published in the literature. It is performed on a daily basis by nurses, and physiotherapists.

In this general context marked by a less aggressive management of orality, and the implementation of an orality stimulation protocol, the main objective of ORAPREM study is to determine the corrected gestational age of oral feeding autonomy in a population of extremely premature infants born recently. Secondary objectives are 1) To analyse risk factors of delay in oral feeding autonomy, to define a subgroup of high-risk infants who could benefit from reinforced interventions to stimulate orality, and 2) To calculate the incidence of oral feeding disorders up to 24 months.

02

Conditions studied

  • Oral Disorders

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03

In context

Mouth Diseases

109 studies on the registry are indexed under Mouth Diseases; 18 are open to participants now.

This study's planned enrollment of 170 is close to the median of 180 across 27 observational studies indexed under Mouth Diseases.

Browse Mouth Diseases studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Preterm newborn born before 28 weeks and hospitalized in the neonatology service of Croix Rousse hospital

Inclusion criteria

  • Infants born at a gestational age ≤ 28 weeks
  • Born between January 1, 2018 and December 31, 2021
  • Admitted in the first three days of life in the neonatology department of the Croix-Rousse hospital
  • Discharged directly to home (or to a nursery)

Exclusion criteria

Exclusion Criteria:

  • Infants re-transferred to another department during hospitalization
  • Infants with a severe pathology requiring surgical management in the first weeks of life. Inguinal hernia repair is not concerned
  • Severe malformation
  • Refusal of the parents
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
170 participants (estimated)
Patient registry
No

Interventions

  • OtherFood autonomy

    Determine the age of acquisition of full oral feeding in extremely premature infants hospitalised in a neonatal unit where that applies a strategy of specific and individualized stimulation of orality.

06

What researchers measure

Primary outcomes

  1. Corrected gestational age at the time of acquisition of full oral feeding

    Corrected gestational age at the time of acquisition of full oral feeding

    Time frame: Up to two months

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Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06648083
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Oct 18, 2024

Study contacts

Pr PICAUD Jean-Charles, MD, PhD
Contact
jean-charles.picaud@chu-lyon.fr
+33472004121

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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