Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

NCT06346236 | Completed

• 2 other identifiers: 69HCL21_0843401
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 3

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 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.

Conditions

Transient Hypothyroxinemia of Prematurity

Keywords

transient hypothyroxinaemia of prematurity, THOP, preterm, prematurity, neurodevelopment, L-thyroxine, ASQ score

Outcome Measures

Primary Outcomes (1)

• Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.

  Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.

  Evaluation at two years of corrected age.

Study Arms (3)

THOP treated

Level of circulating T4 \< 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone \< 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR \< 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration)

Drug: L-thyroxine at a dose of 7.5 µg/kg/d for THOP

THOP un-treated

Level of circulating T4 \< 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone \< 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR \< 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record.

Other: THOP without treatment

No-THOP

all level of circulating T4 \> 12 pmol/L at any time in life

Other: NoTHOP

Interventions

L-thyroxine at a dose of 7.5 µg/kg/d for THOP DRUG

Subjects diagnosed with THOP (as previously defined) and treated with L-thyroxine at a dose of 7.5 µg/kg/d are less likely to have an impaired ASQ score at 4 years of corrected age.

THOP treated

THOP without treatment OTHER

Subjects diagnosed with THOP (as previously defined) and who received no L-thyroxine treatment.

THOP un-treated

NoTHOP OTHER

Subjects diagnosed no-THOP (as previously defined)

No-THOP

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Reanimation and intensive care units of neonatology in Auvergne-Rhone Alpes region (Lyon Croix Rousse hospital, Lyon Femme mère Enfant hospital, St Etienne Hopital Nord, Grenoble Hopital couple enfant).

You may qualify if:

• Premature infants born before or at 3032 weeks of gestation
• For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.

You may not qualify if:

• Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
• Associated polymalformative sindrome

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

HFME

Bron, 69300, France

Location

CHU Grenoble

Grenoble, 38100, France

Location

CHU Saint EtienneHopital

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: March 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

FR (3)