Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945017
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-05-19
Brief Title:
Probiotics and the Neurodevelopment in the Premature Infant 32 Weeks Gestational Age and 1500g
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Organization:
Fundacion Clinic per a la Recerca Biomédica
Study Overview
Official Title:
Probiotics and the Neurodevelopment in the Premature Infant 32 Weeks Gestational Age and 1500g
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
Unicentric quasi-experimental cohort study to evaluate the effect of combining two probiotics Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748 in the neurodevelopment of preterm neonates below 32 weeks gestation and a birthweight under 1500 g This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age Additionally neurodevelopment improved would be more relevant at 6 years of age together with a better pattern of neuronal plasticity biomarkers
Secondarily this mixture of probiotics could reduce NEC LOS intraventricular haemorrhage and neonatal mortality in accordance with previous studies
Secondarily this mixture of probiotics could reduce NEC LOS intraventricular haemorrhage and neonatal mortality in accordance with previous studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None