Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346236
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Brief Title:
Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity
Status:
COMPLETED
Status Verified Date:
2024-03
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:
NEO-TYR
Brief Summary:
Nowadays taking care of preterm birth is associated with an important increase in survival This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation Thyroid hormones are essentials for brain development especially for neuronal differentiation Transient hypothyroxinaemia of prematurity THOP is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates However the biggest and most powerful studies agree to say that THOP impair neurodevelopment On the other hand only a few studies evaluated the impact of treatment of THOP and only two focused on treating exclusively the neonates with a biological diagnosis of THOP Suzumura and co in 2010 and Nomura and co in 2014 and their results are inconsistent
In this study we aim to show that a treatment with L-thyroxine at a dose of 75 µgkgj for neonates diagnosed with THOP defined as a level of l-T4 12 pmolL and a level of TSH 15 mUIL before 15 days of life or 85 mUIL after 15 days of birth is associated with an increased neurodevelopmental prognosis
In this study we aim to show that a treatment with L-thyroxine at a dose of 75 µgkgj for neonates diagnosed with THOP defined as a level of l-T4 12 pmolL and a level of TSH 15 mUIL before 15 days of life or 85 mUIL after 15 days of birth is associated with an increased neurodevelopmental prognosis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 401 | OTHER | AGORA HCL | None |