Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns

N/ANot Yet RecruitingNCT07425028

University Hospital, Lille1,600 enrolled

Overview

Currently in France, screening for congenital hypothyroidism (CH) in premature infants is done by a single TSH assay on filter paper. However, European recommendations advise repeating the assay within the first month of life. Our primary objective is to estimate the incidence of CH in preterm infants under 32 weeks of gestational age by applying the European recommendations.

Study Type

OBSERVATIONAL

Enrollment

1,600

Conditions

Congenital Hypothyroidism

Interventions

Blood testBIOLOGICAL

routine care blood draw

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days), both female and male, of all ethnic origins, regardless of birth weight, and including all other pathologies. * Newborns whose parents have given their non-opposition consent. Exclusion Criteria: * Newborns born who leave the region before day 15. * Newborns who die before 15 days of age. * Newborns whose parents are not affiliated with the social security system.

Locations (1)

Chu de Lille

Lille, France

Outcomes

Primary Outcomes

Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age

The primary objective of the study is to estimate the annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age, within 15 days of birth, by applying the European recommendations, which consist of performing two repeated tests within the first 15 days.

Time frame: From birth to Day 15 of life

Secondary Outcomes

Rate of patient negative to congenital hypothyroidism (CH) test

Time frame: Day 3

Rate of patient positive to congenital hypothyroidism (CH) test

Time frame: Day 15

persistency of congenital hypothyroidism (CH)

For patients with a positive test on Day 3 or Day 15, an evaluation will be conducted at 2 years of age to determine their status: hypothyroidism yes/no

Time frame: 2 years of age

Association between the risk factors mentioned in the literature (predefined factors) and the presence of congenital hypothyroidism in this population of premature infants

Presence of congenital hypothyroidism detected within the first 15 days of life (at Day 3 or Day 15); risk factors mentioned in the literature: intrauterine growth retardation, gestational age, and peri- or postnatal iodine exposure.

Time frame: 15 days at the time of the second sample

Effectiveness of the treatment

After discontinuation of L-thyroxine treatment for more than 1 month: measurement of TSH and free T4 (T4L). Results are classified into two categories: TSH \< 5 mIU/L: transient hypothyroidism; (effective treatment) TSH ≥ 5 mIU/L: permanent hypothyroidism.

Time frame: at 2 years of age

Central Contacts

Christine LEFEVRE, MD

CONTACT

03.20.44.50.70 christine.lefevre@chu-lille.fr

Data from ClinicalTrials.gov

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