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

Analysis of the Factors Influencing the Acquisition of Full Oral Feeding in Very Preterm Infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06648083
Acronym
ORAPREM
Enrollment
170
Registered
2024-10-18
Start date
2024-11-01
Completion date
2025-05-01
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Disorders

Brief 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.

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Weeks
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Corrected gestational age at the time of acquisition of full oral feedingUp to two monthsCorrected gestational age at the time of acquisition of full oral feeding

Countries

France

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026