Oral Feeding Delay Prevention in Preterm Newborns (PARENTALIM)

Caen University Hospital

Status: Completed

Conditions: Preventive Care

Treatments: Other: NIDCAPARENTALIM; Behavioral: SOFS

Study type: Observational

Funder types: Other

Identifiers

NCT06184386

20-161

Details and patient eligibility

About

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 ?

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 3 days to 10 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

43 participants in 2 patient groups

Prospective NIDCAPARENTALIM

Description:

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

Treatment:

Other: NIDCAPARENTALIM

Retrospective SOFS

Description:

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

Treatment:

Behavioral: SOFS