Necrotizing Enterocolitis, Premature Infants
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHigh dose group
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
DIETARY_SUPPLEMENTLow dose group
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
Sponsors
University Hospital Virgen de las Nieves
Hospital Regional de Malaga
Hospital of Jaen
Hospital Costa del Sol
Hospital Universitario Torrecárdenas
Hospital Universitario Virgen Macarena
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
Hospital Universitario de Valme
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Puerta del Mar
Hospital General Universitario Santa Lucia
Hospital del SAS de Jerez
José Antonio Hurtado Suazo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of necrotizing enterocolitis and all-cause mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Late Onset Sepsis | 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) |
| Time to complete enteral nutrition | From birth until three months | Time to reach complete enteral nutrition 140 ml/kg/day |
| Days of Central Vascular Catheter | From birth until three months | — |
| Intestinal colonization by administered strains | From birth until three months | — |
| Weight change | From birth until three months | — |
| Incidence of Bronchopulmonary Dysplasia | From birth until three months | — |
| Incidence of patent ductus arteriosus | From birth until three months | — |
| Length of hospital stay | From birth until three months | Days of hospital stay |
Countries
Spain
Outcome results
None listed