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

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 Overview

• Status: Not yet recruiting
• Conditions: Congenital Hypothyroidism
• Intervention / Treatment: Biological: Blood test

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Christine LEFEVRE, MD; Phone Number: 03.20.44.50.70; Email: christine.lefevre@chu-lille.fr

Study Locations

• France
  • Lille, France
    • CHU de Lille
    • Contact: Christine LEFEVRE, MD; Phone Number: 03.20.44.50.70 Ext.+33; Email: christine.lefevre@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Premature newborns born in maternity wards included in the study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Premature newborn; Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days)	Biological: Blood test; routine care blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From birth to Day 15 of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patient negative to congenital hypothyroidism (CH) test		Day 3
Rate of patient positive to congenital hypothyroidism (CH) test		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	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.	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.	at 2 years of age

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Pierre TOURNEUX, MD, Amiens University Hospital; Principal Investigator: Christine LEFEVRE, MD, University Hospital, Lille; Principal Investigator: Anais GLUSKO-CHARLET, MD, Arras Hospital Center; Principal Investigator: Sylvie MARIETTE, MD, Roubaix Hospital Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prematurity; screening; congenital hypothyroidism
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Thyroid Diseases; Bone Diseases, Endocrine; Bone Diseases, Developmental; Dwarfism; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypothyroidism; Premature Birth; Congenital Hypothyroidism; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: 2022_0207; 2020-A00437-32 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No