Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184386
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-12-14
Brief Title:
Oral Feeding Delay Prevention in Preterm Newborns
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Efficiency of Parental Feeding Support to Strengthen NIDCAP and Favor Eating Development in Preterm Newborns as Compared With a Retrospective Orofacial Stimulation Standardized and Routine Clinical Practice
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARENTALIM
Brief Summary:
Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays Indeed it lengthens hospitalization duration distorts parent-newborns relationships and increases the risks of adverse nursing outcomes Does a routine individualized developmental preventive feeding care implying parents favors earlier autonomous oral feeding achievement in preterm newborns as compared with a standardized routine program of orofacial stimulations despite neonatal risks that every preterm newborn cumulates during hospitalization stay
Detailed Description:
The goal of this observational study is to compare the efficiency of two routine preventive feeding care in preterm newborns taking into account neonatal cumulated risks for each preterm newborn participant The main question it aims to answer is Does a prospective individualized routine developmental preventive feeding care leads to earlier oral feeding achievement in preterm newborns despite individual risks as compared with a retrospective standardized routine program The group of preterm newborns prospectively assigned in the study will be included in NIDCAP strengthen with a parental support on nursing care named PARENTALIM The group of preterm newborns retrospectively assigned in the study received orofacial stimulations in a standardized protocol way SOFS Researchers will compare prospective and retrospective groups to see if the prospective group achieve autonomous oral feeding despite individual neonatal cumulated risks significantly earlier than retrospective group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None