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Completed

NCT Number: NCT06501404

PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.

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Key information

Conditions

Premature Infants Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Virgen de las Nieves

Granada, 18012, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
  • Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.

Exclusion criteria

  • Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
  • Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
  • Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.

Treatment and study plan

High dose group

Dietary Supplement

A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains

Low dose group

Dietary Supplement

A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains

Primary outcomes

  1. Incidence of necrotizing enterocolitis and all-cause mortality

    Time frame: From birth until three months

    The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.

Secondary outcomes

  1. Intestinal colonization by administered strains

    Time frame: From birth until three months

  2. Incidence of Late Onset Sepsis

    Time frame: From birth until three months

    Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture)

  3. Time to complete enteral nutrition

    Time frame: From birth until three months

    Time to reach complete enteral nutrition 140 ml/kg/day

  4. Days of Central Vascular Catheter

    Time frame: From birth until three months

  5. Length of hospital stay

    Time frame: From birth until three months

    Days of hospital stay

  6. Weight change

    Time frame: From birth until three months

  7. Incidence of Bronchopulmonary Dysplasia

    Time frame: From birth until three months

  8. Incidence of patent ductus arteriosus

    Time frame: From birth until three months

Sponsors and collaborators

Lead sponsor

José Antonio Hurtado Suazo

Other

Collaborators

  • Complejo Hospitalario de Especialidades Juan Ramón Jimenez
  • Hospital Costa del Sol
  • Hospital General Universitario Santa Lucia
  • Hospital Regional de Malaga
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario Torrecárdenas
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario de Valme
  • Hospital del SAS de Jerez
  • Hospital of Jaen
  • Hospitales Universitarios Virgen del Rocío
  • University Hospital Virgen de las Nieves

Registry information

Official study title

Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant

Important dates

Study start
2015
Primary completion
2015
Study completion
2020
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

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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