Oral Feeding Delay Prevention in Preterm Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Preventive Care

Intervention / Treatment
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* Other: NIDCAPARENTALIM
* Behavioral: SOFS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective NIDCAPARENTALIM<br>A group of prospectively assigned preterm newborns that will be included in NIDCAP strengthened with a practice focalized on feeding, named PARENTALIM. | Other: NIDCAPARENTALIM<br>* 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.<br>|
| Retrospective SOFS<br>A group of retrospectively assigned preterm newborns that had standardized orofacial stimulations named SOFS. | Behavioral: SOFS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm newborns, individualized developmental care, parental suppport for nursing, orofacial stimulations, oral feeding