Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-02 @ 12:07 AM
Study NCT ID:
NCT06035835
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
Sponsor:
José Uberos Fernández
Organization:
Study Overview
Official Title:
Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: