Oral Feeding Delay Prevention in Preterm Newborns

Preventive Care Clinical Trial

— PARENTALIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06184386
• Other study ID #: 20-161
• Status: Completed
• Start date: February 2, 2019
• Est. completion date: April 15, 2022

Study information

• Verified date: December 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 15, 2022
• Est. primary completion date: February 11, 2019
• Gender: All
• Age group: 3 Days to 10 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preventive Care

Intervention

Other:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Maryse Delaunay	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The duration of oral feeding transition	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.	5 years