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Oral Feeding Delay Prevention in Preterm Newborns

NCT ID: NCT06184386

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-02

Study Completion Date

2022-04-15

Brief Summary

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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

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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.

Conditions

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Preventive Care

Keywords

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preterm newborns individualized developmental care parental suppport for nursing orofacial stimulations oral feeding

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Study Groups

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Prospective NIDCAPARENTALIM

A group of prospectively assigned preterm newborns that will be included in NIDCAP strengthened with a practice focalized on feeding, named PARENTALIM.

NIDCAPARENTALIM

Intervention Type OTHER

PARENTALIM practice that strengthens the NIDCAP. It is proposed in a routine way in the NICU since 2019. PARENTALIM supports and monitors parental implication in nursing care. It is led by a speach language therapist specialized in early feeding development who proposes 5 individualized interviews and uses an educational booklet on eating development care with a lot of illustrations and few words.

Retrospective SOFS

A group of retrospectively assigned preterm newborns that had standardized orofacial stimulations named SOFS.

SOFS

Intervention Type BEHAVIORAL

SOFS is a behavioral practice of orofacial stimulations. Il has been mainly carried out by nurses or a speach language therapist specialized in early feeding development. SOFS has been applied through routine protocol in the NICU until 2018.

Interventions

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NIDCAPARENTALIM

PARENTALIM practice that strengthens the NIDCAP. It is proposed in a routine way in the NICU since 2019. PARENTALIM supports and monitors parental implication in nursing care. It is led by a speach language therapist specialized in early feeding development who proposes 5 individualized interviews and uses an educational booklet on eating development care with a lot of illustrations and few words.

Intervention Type OTHER

SOFS

SOFS is a behavioral practice of orofacial stimulations. Il has been mainly carried out by nurses or a speach language therapist specialized in early feeding development. SOFS has been applied through routine protocol in the NICU until 2018.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Days

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CHRISTEL BLAISON

Role: PRINCIPAL_INVESTIGATOR

Speach language Therapist at University Hospital

Locations

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Maryse Delaunay

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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20-161

Identifier Type: -

Identifier Source: org_study_id