Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
NCT ID: NCT06035835
Last Updated: 2023-09-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
437 participants
Study Classification
OBSERVATIONAL
Study Start Date
2009-01-01
Study Completion Date
2022-03-31
Brief Summary
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The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.
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Detailed Description
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In this study, the investigators analyse the influence of nutrition during the early neonatal period on the development and prevention of atopic dermatitis (AD) in children with a history of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm infants to assess the risk of their developing AD during childhood, according to nutrition with breastmilk and/or probiotic supplementation during the neonatal period. The analysis focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184 received probiotics up to 36 weeks postmenstrual age.
The neonatal history of the patients was consulted in their electronic medical records (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual age; nutricional management; administration of probiotics), and the presence of atopic diseases at school age was corroborated by telephone interviews.
The descriptive date were summarized using medians and interquartile intervals for the continuous variables and distribution frequencies for the categorial variables. Univariate comparisons were made by the Mann-Whitney test for the continuous variables and by the chi-square test for the categorical variables. The association of comorbidities in VLBW newborns and supplementation with one type or another of probiotic was evaluated with a multinomial regression analysis, ajustando por las variables que mostraron diferencias en el análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS 20.0 for Windows software
The neonatal history of the patients was consulted in their electronic medical records (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual age; nutricional management; administration of probiotics), and the presence of atopic diseases at school age was corroborated by telephone interviews.
The descriptive date were summarized using medians and interquartile intervals for the continuous variables and distribution frequencies for the categorial variables. Univariate comparisons were made by the Mann-Whitney test for the continuous variables and by the chi-square test for the categorical variables. The association of comorbidities in VLBW newborns and supplementation with one type or another of probiotic was evaluated with a multinomial regression analysis, ajustando por las variables que mostraron diferencias en el análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS 20.0 for Windows software
Conditions
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Atopic Dermatitis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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Probiotic 1
Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age
Lacticaseibacillus rhamnosus
Intervention Type
COMBINATION_PRODUCT
Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)
Probiotic 2
Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age
Lactobacillus acidophilus + Bifidobacterium bifidum
Intervention Type
COMBINATION_PRODUCT
Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)
No probiotic
No suplementation diet with probiotic
No interventions assigned to this group
Interventions
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Lacticaseibacillus rhamnosus
Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)
Intervention Type
COMBINATION_PRODUCT
Lactobacillus acidophilus + Bifidobacterium bifidum
Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)
Intervention Type
COMBINATION_PRODUCT
Eligibility Criteria
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Inclusion Criteria
* Newborn with a gestational age \< or = 32 weeks and/or birth weight \< or = 1500 grams.
Exclusion Criteria
* Incomplete health history record o lack of data.
* Severe congenital anomalies.
* Severe congenital anomalies.
Maximum Eligible Age
32 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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José Uberos Fernández
OTHER
Sponsor Role
lead
Responsible Party
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José Uberos Fernández
Head of Unit Care Neonatology, Principal Investigator, Clinical Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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José Uberos-Fernández, Mr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario San Cecilio
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://www.seneo.es/images/site/publicaciones/libros/Nutricion_parenteral.pdf
Uberos, J., Narbona, E., Gormaz, M., Lines, M., Rodríguez, G., Saenz de Pipaón, M. and Couce, M., 2017b. Nutrición parenteral en el recién nacido prematuro de muy bajo peso. Propuesta de un protocolo de actuación tras revisión de la evidencia científica.
Other Identifiers
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BM-2022-12-0144.R2
Identifier Type: -
Identifier Source: org_study_id
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