Oral Feeding Delay Prevention in Preterm Newborns

Completed

• Conditions: Preventive Care
• Interventions: Other: NIDCAPARENTALIM; Behavioral: SOFS

• Registration Number: NCT06184386
• Lead Sponsor: University Hospital, Caen

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 Timeline

• Study Start: 2019-02-02
• Primary Completion: 2019-02-11
• Study Completion: 2022-04-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Parents of preterm newborns born before 34 weeks of amenorrhea
• Parents who agree participating in the study after signing an informed consent.
• Minimal delay of 72 hours and maximal delay of 15 days after birth to inform parents and wait their consent.

Exclusion Criteria

• Parents of preterm newborns born after 35 weeks of amenorrhea
• Parents who disagree participating in the study, even after signing the informed consent.
• Parents of preterm newborns born with cerebral, maxillo-facial, digestive, cardiac, genetic or syndromic abnormalities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective NIDCAPARENTALIM	NIDCAPARENTALIM	A group of prospectively assigned preterm newborns that will be included in NIDCAP strengthened with a practice focalized on feeding, named PARENTALIM.
Retrospective SOFS	SOFS	A group of retrospectively assigned preterm newborns that had standardized orofacial stimulations named SOFS.

Primary Outcome Measures

Name	Time	Method
The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks	5 years	The corrected age in ammenorhea weeks at which preterm newborn achieve autonomous oral feeding will be divided by the index of cumulated neonatal risks scored from the updated risk inventory initially proposed by Sheiner and Sexton in 1991

Secondary Outcome Measures

Name	Time	Method
The duration of oral feeding transition	5 years	The duration from the moment when preterm newborn takes 5 ml per kg per day and until the moment when autonomous oral feeding is achieved.

Trial Locations

Locations (1)

Maryse Delaunay; 🇫🇷 Caen, Normandy, France