Clinical trial NCT06035835: Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
Official title: Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Probiotics
Human breastmilk
newborn
very low birth weight
atopic eczema
Lead sponsor: Hospital Clinico Universitario San Cecilio
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 437
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn with a gestational age \< or = 32 weeks and/or birth weight \< or = 1500 grams born at our hospital (Hospital Universitario Clínico San Cecilio, Granada) between January 2009 and December 2021.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change incidence of atopic dermatitis in children receiving probiotics
timeFrame: From birth to January 2023
measure: To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children.
timeFrame: From birth to January 2023
measure: Identify probiotic strains that may decrease the incidence of atopic dermatitis.
timeFrame: From birth to January 2023
measure: Influence of caloric intake on the development of atopic dermatitis
timeFrame: From birth to January 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinico Universitario San Cecilio
name: José Uberos-Fernández, Mr
role: PRINCIPAL_INVESTIGATOR
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