Oral Feeding Delay Prevention in Preterm Newborns

NCT06184386 | Completed DMC

• 1 other identifier: 20-161
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Preventive Care

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks

  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

  5 years

Secondary Outcomes (1)

• The duration of oral feeding transition

  5 years

Study Arms (2)

Prospective NIDCAPARENTALIM

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

Other: NIDCAPARENTALIM

Retrospective SOFS

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

Behavioral: SOFS

Interventions

NIDCAPARENTALIM 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.

Prospective NIDCAPARENTALIM

SOFS 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.

Retrospective SOFS

Eligibility Criteria

• Age: 3 Days - 10 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm newborns born before 34 weeks of amenorrhea with variable but moderated neonatal risks and their parents.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Maryse Delaunay

Caen, Normandy, 14000, France

Location

Study Officials

• CHRISTEL BLAISON

  Speach language Therapist at University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: February 2, 2019
• Primary Completion: February 11, 2019
• Study Completion: April 15, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

FR (1)