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NCT Number: NCT05945017

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers.

Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

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Key information

Conditions

Infant, Newborn, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant Development Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonataology Service, BCNatal Hospital Clinic Seu Maternitat

Barcelona, 08028, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature infants under 32 weeks gestational age and less than 1500g birthweight.
  • Born at BCNatal Hospital Clínic between years 2014-2019.

Exclusion criteria

  • All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded.
  • Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

Treatment and study plan

Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748

Dietary Supplement

Primary outcomes

  1. Degree of neurodevelopment at 24 months corrected age

    Time frame: 24 months

    Normal neurodevelopment will be considered when no muscle tone changes, no impaired fine or gross motor coordination, Bayley scale score between above 84, no behaviour disorders or visual disability.

  2. Degree of neurodevelopment at 24 months corrected age

    Time frame: 24 months

    Mild impairment will be considered if any of the following: muscle tone changes, impaired fine or gross motor coordination, Bayley scale score between 71-84, moderate behaviour disorders or mild visual disability.

  3. Degree of neurodevelopment at 24 months corrected age

    Time frame: 24 months

    Moderate impairment will be diagnosed when suffering from any of the following: spastic diplegia, hemiplegia, seizures (non-febrile), Bayley scores between 50-70, severe behaviour disorders, moderate visual disability or mild-moderate hypoacusis.

  4. Degree of neurodevelopment at 24 months corrected age

    Time frame: 24 months

    Severe impairment will be attributed to subjects with any of the following: spastic quadriplegia, choreoathetosis, ataxia, Bayley score <50, blindness or severe hypoacusis

  5. Degree of neurodevelopment at 6 years of age

    Time frame: 6 years

    Wechsler Intelligence Scale for Children - Fifth edition. Ranges from below 69 to above 130. Scores from 90-109 indicate average, above it indicates above average and below, below average performance.

  6. Degree of neurodevelopment at 6 years of age

    Time frame: 6 years

    Child behaviour checklist 6-18 years of age. 113 items about behaviour and social competence scored from 0 "absent" to 2 "occurs often"

  7. Degree of neurodevelopment at 6 years of age

    Time frame: 6 years

    Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2). Parent/teacher self reporting form.

  8. Neuroplasticity biomarkers and intestinal permeability

    Time frame: 6 years

    NeuN, Doublecortin, GFAP, GDNF, Ki67, Nrf2, BDNF, NGF, neurotrophin-1 (NT-1), neurotrophin-3 (NT-3), neurotrophin-4 (NT-4), DYRK1A, HIF1α, S100B i GSK3B. IL1B, IL6, IL8, IL10, IL12, TNF- α

Secondary outcomes

  1. Incidence of necrotising enterocolitis

    Time frame: 40 weeks

    cases fulfilling the stage II or above of the modified Bell's Criteria

  2. Mortality

    Time frame: 40 weeks

    Proportion of dead participants before discharge

  3. Incidence of late onset sepsis

    Time frame: 40 weeks

    positive blood culture beyond 72 hours of life

  4. Incidence of Intraventricular haemorrhage

    Time frame: 40 weeks

    Grade I-IV

  5. Intensive care length of stay

    Time frame: 40 weeks

    Days of intensive care

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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