{
  "abstract": "Introduction Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.Methods and analysis Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.Ethics and dissemination Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).Trial registration number NCT04685356.",
  "authors": [
    {
      "affiliations": [
        "Departement of Neonatal Medicine and Pediatric Critical Care Medecine, Brest University Hospital Centre, Brest, Bretagne, France"
      ],
      "name": "Meghan Smith"
    },
    {
      "affiliations": [
        "Departement of Neonatal Medicine and Pediatric Critical Care Medecine, Strasbourg University Hospitals, Strasbourg, Grand Est, France",
        "Institut des Neurosciences Cellulaires et Intégratives, CNRS UPR 3212, Strasbourg University, Strasbourg, France"
      ],
      "name": "Pierre Kuhn"
    },
    {
      "affiliations": [
        "Department of Neonatal and Pediatric Emergency, Besançon Regional University Hospital Center, Besancon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Gerard Thiriez"
    },
    {
      "affiliations": [
        "Neonatal Intensive Care Unit, Grenoble Alpes University Hospital, Grenoble, France"
      ],
      "name": "Thierry Debillon"
    },
    {
      "affiliations": [
        "Department of Neonatology, University Hospital Centre Caen, Caen, Basse-Normandie, France"
      ],
      "name": "Valérie Datin-Dorrière"
    },
    {
      "affiliations": [
        "Department of Neonatalogy and Neonatal Intensive Care, University Hospital Centre Angers, Angers, Pays de la Loire, France"
      ],
      "name": "Bertrand Leboucher"
    },
    {
      "affiliations": [
        "Department of Neonatology, Regional University Hospital Centre Tours Bretonneau Hospital, Tours, Centre-Val de Loire, France"
      ],
      "name": "Delphine Mitanchez"
    },
    {
      "affiliations": [
        "Biostatistics and Methodology Team,Department of Clinical Research and Innovation, Brest University Hospital Centre, Brest, Brittany, France"
      ],
      "name": "Emmanuelle Courtois-Communier"
    },
    {
      "affiliations": [
        "Department of Neonatal Medicine, University Hospital Centre Toulouse, Toulouse, Occitanie, France"
      ],
      "name": "Jacques Sizun"
    },
    {
      "affiliations": [
        "Departement of Neonatal Medicine and Pediatric Critical Care Medecine, Brest University Hospital Centre, Brest, Bretagne, France"
      ],
      "name": "Jean-Michel Roué"
    }
  ],
  "title": "Infant behavioural assessment and intervention program to support neurodevelopmental outcome of very preterm infants at two years corrected age: a cluster randomised controlled trial study protocol",
  "uid": "cb2dbc75-87ae-5ba5-b7c3-6d61fa28dc39"
}