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Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.

Identifieur interne : 000284 ( Main/Exploration ); précédent : 000283; suivant : 000285

Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.

Auteurs : Sophie Laborie [France] ; Angelique Denis [France] ; Antje Horsch [Suisse] ; Pauline Occelli [France] ; Jennifer Margier [France] ; Mathilde Morisod Harari [Suisse] ; Olivier Claris [France] ; Sandrine Touzet [France] ; Celine Julie Fischer Fumeaux [Suisse]

Source :

RBID : pubmed:32005780

Descripteurs français

English descriptors

Abstract

INTRODUCTION

Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries.

METHODS AND ANALYSIS

Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup.

ETHICS AND DISSEMINATION

French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes.

TRIAL REGISTRATION NUMBER

NCT03156946.


DOI: 10.1136/bmjopen-2019-032910
PubMed: 32005780
PubMed Central: PMC7045006


Affiliations:


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<term>Adult (MeSH)</term>
<term>Breast Feeding (statistics & numerical data)</term>
<term>Counseling (methods)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Infant, Newborn (MeSH)</term>
<term>Infant, Premature (MeSH)</term>
<term>Intensive Care Units, Neonatal (statistics & numerical data)</term>
<term>Male (MeSH)</term>
<term>Mothers (psychology)</term>
<term>Peer Group (MeSH)</term>
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<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte (MeSH)</term>
<term>Allaitement naturel (statistiques et données numériques)</term>
<term>Assistance (méthodes)</term>
<term>Femelle (MeSH)</term>
<term>Groupe de pairs (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Mères (psychologie)</term>
<term>Nouveau-né (MeSH)</term>
<term>Prématuré (MeSH)</term>
<term>Unités de soins intensifs néonatals (statistiques et données numériques)</term>
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<term>Femelle</term>
<term>Groupe de pairs</term>
<term>Humains</term>
<term>Mâle</term>
<term>Nouveau-né</term>
<term>Prématuré</term>
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<div type="abstract" xml:lang="en">
<p>
<b>INTRODUCTION</b>
</p>
<p>Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS AND ANALYSIS</b>
</p>
<p>Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>ETHICS AND DISSEMINATION</b>
</p>
<p>French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION NUMBER</b>
</p>
<p>NCT03156946.</p>
</div>
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<AbstractText Label="INTRODUCTION">Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries.</AbstractText>
<AbstractText Label="METHODS AND ANALYSIS">Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup.</AbstractText>
<AbstractText Label="ETHICS AND DISSEMINATION">French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER">NCT03156946.</AbstractText>
<CopyrightInformation>© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation>
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<ForeName>Sophie</ForeName>
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<Affiliation>Hopital Femme Mère Enfant, Neonatology, Hospices Civils de Lyon, Bron, France sophie.laborie@chu-lyon.fr.</Affiliation>
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<AffiliationInfo>
<Affiliation>Equipe P2S4129, Université Claude Bernard Lyon 1, Villeurbanne, Auvergne-Rhône-Alpes, France.</Affiliation>
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<ForeName>Sandrine</ForeName>
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<Affiliation>Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.</Affiliation>
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<AffiliationInfo>
<Affiliation>Laboratoire Health Services and Performance Research (HESPER) EA 7425, Université de Lyon 1, Villeurbanne, France.</Affiliation>
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<LastName>Fischer Fumeaux</LastName>
<ForeName>Celine Julie</ForeName>
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<name sortKey="Horsch, Antje" sort="Horsch, Antje" uniqKey="Horsch A" first="Antje" last="Horsch">Antje Horsch</name>
<name sortKey="Morisod Harari, Mathilde" sort="Morisod Harari, Mathilde" uniqKey="Morisod Harari M" first="Mathilde" last="Morisod Harari">Mathilde Morisod Harari</name>
</country>
</tree>
</affiliations>
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