{
  "abstract": "Objective To compare growth, tolerance and safety parameters in very preterm infants receiving human milk (HM) fortified with a multicomponent cow’s milk-based HM fortifier (HMF; control) versus a novel HMF-containing lipids (including docosahexaenoic acid and arachidonic acid), higher protein and lower carbohydrate levels (test). Our hypothesis was that weight growth velocity in the test group would be non-inferior to that in the control group.Design Double-blind, randomised controlled trial.Setting Nine European neonatal intensive care units.Patients HM-fed infants born at <32-week gestational age.Interventions Fortification of HM with Test or Control HMF for a minimum of 21 days.Primary outcome Weight growth velocity between baseline and intervention day 21.Results From March 2018 to July 2020, 102 and 103 infants were enrolled in the test and control groups, respectively. Weight growth velocity during the first 21 days in the test group (mean 18.4 g/kg/day) was non-inferior to that of controls (mean 18.5 g/kg/day), with a difference in estimated means of –0.175 g/kg/day (90% CI –1.34 to +0.99 g/kg/day; per-protocol population). No significant differences between groups were observed for gain in length, head circumference or anthropometric Z-scores. Rates of digestive intolerance, stool frequency and consistency were comparable. No significant differences were reported in common neonatal morbidities including necrotising enterocolitis (test: 2.9%, control: 6.9%, mean difference –4.0% (95% CI –11.1% to 2.2%); all subjects treated population).Conclusions Use of the novel HMF containing lipids, higher protein and lower carbohydrate levels supports adequate postnatal growth and appears safe and well tolerated in very preterm infants.Trial registration number NCT03315221",
  "authors": [
    {
      "affiliations": [
        "Neonatologie, Hôpital de la croix rousse, Hospices Civils de Lyon, Lyon, France",
        "Laboratoire CarMen, Université Claude Bernard Lyon 1, Faculté de médecine Lyon Sud, Pierre Bénite, France"
      ],
      "name": "Jean-Charles Picaud"
    },
    {
      "affiliations": [
        "Neonatal Intensive Care Unit, St. Peter's Hospital, Ashford & St. Peter’s Hospitals NHS Foundation Trust, Chertsey, Surrey, UK"
      ],
      "name": "Peter Robert Reynolds"
    },
    {
      "affiliations": [
        "Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich Medical School, University of East Anglia, Norwich, UK"
      ],
      "name": "Paul Clarke"
    },
    {
      "affiliations": [
        "Danone Research Centre for Specialised Nutrition, Danone Research Centre for Specialised Nutrition, Utrecht, The Netherlands"
      ],
      "name": "Edith van den Hooven"
    },
    {
      "affiliations": [
        "Department of Neonatology, Emma Children’s Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"
      ],
      "name": "Mirjam M van Weissenbruch"
    },
    {
      "affiliations": [
        "Department of Neonatology, Isala Women and Children’s hospital, Zwolle, The Netherlands"
      ],
      "name": "Richard A van Lingen"
    },
    {
      "affiliations": [
        "Danone Research Centre for Specialised Nutrition, Danone Research Centre for Specialised Nutrition, Utrecht, The Netherlands"
      ],
      "name": "Annemiek Goedhart"
    },
    {
      "affiliations": [
        "Danone Research Centre for Specialised Nutrition, Danone Research Centre for Specialised Nutrition, Utrecht, The Netherlands"
      ],
      "name": "Akke Botma"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Otto-von-Guericke Universitatsklinikum Magdeburg, Magdeburg, Germany"
      ],
      "name": "Ralf Boettger"
    },
    {
      "affiliations": [
        "Department of Neonatology, Maastricht University Medical Centre, Maastricht, The Netherlands"
      ],
      "name": "Elke van Westering-Kroon"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Paracelsus Medical School, Nuremberg, Germany"
      ],
      "name": "Christoph Fusch"
    },
    {
      "affiliations": [
        "Service de Néonatologie, Maternité Régionale CHRU Nancy, Nancy, France"
      ],
      "name": "JM Hascoet"
    },
    {
      "affiliations": [],
      "name": "RENOIR Study Group"
    }
  ],
  "title": "A novel human milk fortifier supports adequate growth in very low birth weight infants: a non-inferiority randomised controlled trial",
  "uid": "ef4d4086-6a2b-53c1-bb7c-01c37bb2c75b"
}