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Background and objective <p>Extremely preterm infants are at very high risk of neonatal death and disabilities. Their survival rate is much variable in developed countries and in France is much lower than other countries. Our objective is to evaluate the impact of an intervention to standardize the perinatal management of extremely preterm infants.</p> Population <p>Women hospitalized between 22 and 26&#xa0;weeks for risk of preterm delivery with a alive fetus or a stillbirth at admission and with a delivery between 22 and 26 completed weeks.</p> Intervention <p>Our complex intervention aimed at standardizing the organization of care based on the following principles: A collective obstetric-pediatric prognostic assessment, in a non-emergency setting, with a consensus decision about the obstetric and neonatal management proposed—either active or palliative care; An interview with the parents to inform them, answer their questions, propose either active or palliative care and then ask their opinion.</p> Methods <p>A Stepped-wedge cluster-randomized trial. Perinatal networks will be randomly allocated to the intervention in 5 waves every 3&#xa0;months, with a total recruitment period of 21&#xa0;months (including 3-month transition periods). All perinatal networks will have a period with and without the intervention. After the allocation of clusters to the intervention period, the teams will be trained in the intervention protocol and then will undergo a 3-month transition period to learn the protocol thoroughly.</p> Sample size <p>We hypothesis hypothesized is that survival without severe morbidity will could rise from 20 to 35% after the intervention, but envisaged different scenarios with varying survival without severe morbidity in the control and intervention periods. The intraclass correlation coefficients was set to 0.07. With an average number of 60 to 70 extremely preterm infants recruited per year, a number of 20 clusters (perinatal networks) were was sufficient to provide at least 80% power in most scenarios, and 25 clusters would provide at least 80% power in all scenarios envisaged.</p> Setting <p>Twenty-five perinatal networks including 34 neonatal level-3 hospital, and 285 maternity units overall.</p> Outcome <p>Child's survival without severe morbidity at hospital discharge.</p> Expected results <p>Improvement of the health of extremely preterm infants and, if the intervention shows that it is effective, equitable access to care according to place of birth in France.</p> Ethics <p>The protocol was approved by the Committee for Protection of Persons Involved in&#xa0;Biomedical Research (CPP Ile de France V PARIS), and the French Data Protection Authority (30/12/2021, N°21.03700000050-MS02).</p> Trial registration <p>The trial was registered before the beginning of the study at ClinicalTrials.gov (December 20, 2021—NCT05248477).</p>

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Impact of an intervention standardizing the perinatal management of extremely preterm infants on the child’s survival without severe morbidity: a stepped-wedge cluster-randomized trial (PREMEX study)

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  • 发表日期：

    2026年5月6日

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  • François Goffinet,
  • Pierre-Yves Ancel,
  • Hendy Abdoul,
  • Isabelle Durand-Zaleski,
  • Isabelle Boutron,
  • Raphaël Porcher,
  • Pierre-henri Jarreau,
  • Arthur Foulon,
  • Pierre Tourneux,
  • René Gabriel,
  • Nathalie Bednarek,
  • Amjad Kattini,
  • Ali Bilal,
  • Emmanuel Simon,
  • Denis Semama,
  • Olivier Morel,
  • Apolline Wittwer,
  • Nicolas Mottet,
  • Gerard Thiriez,
  • Léa Delhomme,
  • Elizabeth Grossetti,
  • Henri Bruel,
  • Michel Dreyfus,
  • Valérie Datin-Dorriere,
  • Claudia Brie,
  • Anne-Sophie Pages,
  • Florent Angot,
  • Sarah Herrmann,
  • Stéphane Rioualen,
  • Claire Combescure,
  • Oriane Vetier,
  • Jennifer Chauvel,
  • Corinne Cudeville,
  • Doriane Madelenau,
  • Norbert Winer,
  • Cyril Flamant,
  • Philippe Gillard,
  • Bertrand Leboucher,
  • Stéphane Le Bouédec,
  • Sophie Blanchet,
  • Hélène Basset,
  • Coralie Dufour,
  • Caroline Diguisto,
  • Delphine Mitanchez,
  • Didier Riethmuller,
  • Thierry Debillon,
  • Denis Gallot,
  • Benoît Boeuf,
  • Gilles Kayem,
  • Pierre Delorme,
  • Laurence Foix-L’Helias,
  • Simon Crequit,
  • Patrick Daoud,
  • Tatiana Souaid,
  • Mireille Ruiz,
  • Alizée Lori,
  • Thibaud Quibel,
  • Mathilde Letouzey,
  • Christophe Poncelet,
  • Suzanne Borrhomee,
  • Nathalie Tordjeman,
  • Désirée Andriamanjato,
  • Loïc Sentilhes,
  • Hugo Madar,
  • Olivier Tandonnet,
  • Anita Hastoy,
  • Justine Labat,
  • Caroline Bohec,
  • Claire Mas,
  • Paul Guerby,
  • Marguerite Nau,
  • Florent Fuchs,
  • Gilles Cambonie,
  • Vincent Letouzey,
  • Massimo Di Maio,
  • Nathalie Clainquart,
  • Sarah Renard,
  • Chloé Lapeyre,
  • Noureddine Hedjem,
  • Cinthia Trastour,
  • Sergio Eleni Dit Trolli,
  • Claude d’Ercole,
  • Julie Blanc,
  • Barthélémy Tosello,
  • Aurélie Garbi,
  • Florence Bretelle,
  • Farid Boudred,
  • Marion Mottier,
  • Nirmalan Yoharajah,
  • Charly Larrieu,
  • Jeanne Sibiude,
  • Olivier Anselem,
  • Jacques Lepercq,
  • Aude Girault,
  • Laurence Boujenah,
  • Juliana Patkaï,
  • Héloïse Torchin,
  • Charlotte Bouvard,
  • Audrey Reynaud,
  • Elisabeth Le Meur,
  • Audrey Le Taro,
  • Nathalie Leloux,
  • Elodie Tisserand,
  • Ombeline Desplanches,
  • Thomas Desplanches,
  • Paul Sagot,
  • Emilie Marrer,
  • Margaux Creutz-Leroy,
  • Blandine Mulin,
  • Laurence Guerin,
  • Delphine Boscher,
  • Catherine Leveque,
  • Annie Letardif,
  • Jean Coudray,
  • Jean-Louis Simenel,
  • Elodie Savajols,
  • Amélie Lemaître,
  • Valérie Rouger,
  • Isabelle Berlie,
  • Martine Hérault,
  • Rozenn Colin,
  • Léna Rivier,
  • Thierry Perez,
  • Antoun Souhaid,
  • Audrey Monteiro,
  • Marie-Carole Baude,
  • Bénédicte Lecomte,
  • Aurélie Pion,
  • Marianne Jeannin,
  • Anne Ego,
  • Rebecca Sebbah,
  • Françoise Vendittelli,
  • Anne Legrand,
  • Isabelle Hamant,
  • Michèle Granier,
  • Béatrice Clorennec,
  • Christine Paday,
  • Nathalie Baunot,
  • Manuela Briand,
  • Michèle Manière,
  • Sabrina Hedhili,
  • Audrey Rolland,
  • Caroline Dupont,
  • Camille Bouyer,
  • Anne Dubois,
  • Laureline Mathieu,
  • Audrey Diarra,
  • Muriel Rebola,
  • Stéphanie de Bortoli,
  • Annie Campagne,
  • Christophe Savagner,
  • Isabelle Souksi,
  • Evelyne Mazurier,
  • Dominique Foissin,
  • Olivier Thibeaugeorges,
  • Armelle Bertrand,
  • Thiery Fabien,
  • Nathalie Laurenceau,
  • Benjamin Coppel,
  • Jérôme Bellec,
  • Patricia Garcia,
  • Meriem Zahed-Cheikh,
  • Anne-Marie Maillotte,
  • Nicolas Fontanarosa,
  • Nathalie Agostini,
  • Sophie Bertrand,
  • Sophie De Butler,
  • Fanny Schotter,
  • Ali Hamza,
  • Michel Ruckstuhl,
  • Benoît Garriot,
  • Jennifer Lerouge,
  • Florence Dufour,
  • Hélène Dedreux,
  • Emmanuelle Neyme,
  • Laurence Dutartre,
  • William Mutamba,
  • Charlotte Patte,
  • Philippe Lemarie,
  • Amoudou Laico Traore,
  • Anaïs Limousin,
  • Hélène Minebois,
  • Bérénice Fanjeaux,
  • Mathilde Tournier,
  • Sheila Frechou,
  • Gilles Levy,
  • Camille Rosière,
  • Suzette Eira Roth,
  • Camille Sauve,
  • Marie Grall,
  • Flora Roblot,
  • Marie-Pierre Berte,
  • Mélanie Rouleau,
  • Marie-Noëlle Neveu,
  • Delphine Leclerc,
  • Auréline D’Antona,
  • Clémentine Vidal,
  • Stephan Miot,
  • Virginie Kremer,
  • Marc Dommergues,
  • Jessica Dahan-Saal,
  • Anne-Gaëlle Cordier,
  • Imène Sellahi,
  • Amélie Benbara,
  • Brigitte Clauw,
  • Alexandra Maffre,
  • Christine Léon,
  • Laure Perez,
  • Aurélien Mattuizzi,
  • Marion Isool Hooper,
  • Marie-Lise Dorsier,
  • Anne Bord-Batany,
  • Christine Bouffard,
  • Clémentine Guérin,
  • May-Lise Bouvet,
  • Anne Chartois,
  • Laura Mizzi-Rozier,
  • Slah Mrad,
  • Estelle Vaucan,
  • Anne Henry-Clery,
  • Benjamin Van Cortenbosch,
  • Isabelle Sicre,
  • Crisitina Timisescu,
  • Marianne Picard,
  • Elisabeth Roubelat,
  • Thierry Lecine,
  • Claire Pieron,
  • Cécile Carayol,
  • Julia Di Piazza,
  • Pascal Zephir,
  • Julie Raignoux,
  • Corinne Souyris,
  • Anne Siri,
  • Sabine Charpentier,
  • Florence Coste,
  • Marie Alessandrie,
  • Katia Ducros,
  • Lilian Vincent,
  • Talal Douksi,
  • Emilie Ricard,
  • Nathalie Alma,
  • Daniel Cohen,
  • Sophie Abbink,
  • Edwin Quarello,
  • Xavier Donato,
  • Nathalie Lavergne,
  • Valérie Quay,
  • Valérie Verlomme,
  • Magalie Biferi

摘要

Background and objective

Extremely preterm infants are at very high risk of neonatal death and disabilities. Their survival rate is much variable in developed countries and in France is much lower than other countries. Our objective is to evaluate the impact of an intervention to standardize the perinatal management of extremely preterm infants.

Population

Women hospitalized between 22 and 26 weeks for risk of preterm delivery with a alive fetus or a stillbirth at admission and with a delivery between 22 and 26 completed weeks.

Intervention

Our complex intervention aimed at standardizing the organization of care based on the following principles: A collective obstetric-pediatric prognostic assessment, in a non-emergency setting, with a consensus decision about the obstetric and neonatal management proposed—either active or palliative care; An interview with the parents to inform them, answer their questions, propose either active or palliative care and then ask their opinion.

Methods

A Stepped-wedge cluster-randomized trial. Perinatal networks will be randomly allocated to the intervention in 5 waves every 3 months, with a total recruitment period of 21 months (including 3-month transition periods). All perinatal networks will have a period with and without the intervention. After the allocation of clusters to the intervention period, the teams will be trained in the intervention protocol and then will undergo a 3-month transition period to learn the protocol thoroughly.

Sample size

We hypothesis hypothesized is that survival without severe morbidity will could rise from 20 to 35% after the intervention, but envisaged different scenarios with varying survival without severe morbidity in the control and intervention periods. The intraclass correlation coefficients was set to 0.07. With an average number of 60 to 70 extremely preterm infants recruited per year, a number of 20 clusters (perinatal networks) were was sufficient to provide at least 80% power in most scenarios, and 25 clusters would provide at least 80% power in all scenarios envisaged.

Setting

Twenty-five perinatal networks including 34 neonatal level-3 hospital, and 285 maternity units overall.

Outcome

Child's survival without severe morbidity at hospital discharge.

Expected results

Improvement of the health of extremely preterm infants and, if the intervention shows that it is effective, equitable access to care according to place of birth in France.

Ethics

The protocol was approved by the Committee for Protection of Persons Involved in Biomedical Research (CPP Ile de France V PARIS), and the French Data Protection Authority (30/12/2021, N°21.03700000050-MS02).

Trial registration

The trial was registered before the beginning of the study at ClinicalTrials.gov (December 20, 2021—NCT05248477).