Clinical trial NCT06184386: Oral Feeding Delay Prevention in Preterm Newborns
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preventive Care
Keywords: preterm newborns
individualized developmental care
parental suppport for nursing
orofacial stimulations
oral feeding
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 43
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm newborns born before 34 weeks of amenorrhea with variable but moderated neonatal risks and their parents.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks
timeFrame: 5 years
Secondary outcomes:
measure: The duration of oral feeding transition
timeFrame: 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Maryse Delaunay
state: Normandy
Study officials:
affiliation: Speach language Therapist at University Hospital
name: CHRISTEL BLAISON
role: PRINCIPAL_INVESTIGATOR
References: