Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657729
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Oral Feeding Skills of Very Premature Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Oral Feeding Skills of Very Premature Infants
Status:
NOT_YET_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:
NUTRIO
Brief Summary:
Extremely premature infants born at a gestational age GA of less than 29 weeks are exposed to numerous complications in the neonatal period digestive cardiac infectious respiratory neurological and in the longer term neurosensory and cognitive development impaired growth oral feeding disorders In premature babies non-nutritive sucking is present from 27 weeks gestation but the suck swallow breathe sequence which is essential for feeding autonomy does not mature until 34 weeks with wide individual variations Therefore preterm newborns initially needs a gastric tube to receive enteral nutrition During this period the oral sphere is often dys-stimulated by the insertionattachment of the gastric tube aspirations of oral secretions etc The earlier children are born the more frequent and serious the pathologies associated with prematurity the more frequent these dys-stimulations are and the longer enteral feeding via gastric tube is required As a result the more immature the child the more the development of oral performance is disrupted This disrupts the transition from enteral feeding to oral feeding and therefore the acquisition of autonomous feeding which is essential if the child is to be able to go out at home This has an impact on the length of hospitalisation Individualised developmental care the current standard of care in neonatology aims on the one hand to reduce dys-stimulation and on the other hand to offer positive oral stimulation such as non-nutritive sucking and perioral stimulation Non-nutritive sucking consists of providing the child with a dummy as often and for as long as possible ie as soon as the child is awake Some departments also use specific and adapted perioral stimulation protocols For several years the department of neonatology at the Croix Rousse University Hospital included in care protocols a protocol for peri-oral stimulation It begins as soon as the baby is no longer suffering from any major haemodynamic or respiratory problems It is stopped when feeding is active and autonomy has been achieved It consists of stimulating the perioral and oral area ideally four times a day when the child is awake and particularly before meals Perioral stimulation is performed on the babys face then depending on the babys reactions oral stimulation is performed using a cotton bud soaked in milk When the baby places his tongue in the sucking position and closes his lips oral feeding can begin
In a retrospective single-centre study carried out in neonatology at the Croix Rousse hospital in 163 babies born before 29 weeks gestation the investigator calculated that the average corrected GA for the acquisition of feeding autonomy was 383 weeks gestation with significant inter-individual variability
The hypothesis is that extremely premature infants already have oral skills very early then lose them due to the numerous dys-stimulations of the oral sphere during intensive care period Stimulations of the oral and perioral sphere implemented early could make it possible to limit this loss of competence and to observe a physiological evolution of oral skills
In a retrospective single-centre study carried out in neonatology at the Croix Rousse hospital in 163 babies born before 29 weeks gestation the investigator calculated that the average corrected GA for the acquisition of feeding autonomy was 383 weeks gestation with significant inter-individual variability
The hypothesis is that extremely premature infants already have oral skills very early then lose them due to the numerous dys-stimulations of the oral sphere during intensive care period Stimulations of the oral and perioral sphere implemented early could make it possible to limit this loss of competence and to observe a physiological evolution of oral skills
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