Skip to main content
OpenTrials
Completed

NCT Number: NCT06184386

Oral Feeding Delay Prevention in Preterm Newborns

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 ?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preventive Care

Age range

3 day–10 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Maryse Delaunay

Caen, Normandy, 14000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. The duration of oral feeding transition

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: PARENTALIM

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Dec 28, 2023
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.