Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648083
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analysis of the Factors Influencing the Acquisition of Full Oral Feeding in Very Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORAPREM
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None