Clinical trial NCT06648083: Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Official title: Analysis of the Factors Influencing the Acquisition of Full Oral Feeding in Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Disorders
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 170
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm newborn born before 28 weeks and hospitalized in the neonatology service of Croix Rousse hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Corrected gestational age at the time of acquisition of full oral feeding
timeFrame: Up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Croix Rousse
Study officials:
References: