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

NCT07425028 | Not Yet Recruiting

• 2 other identifiers: 2022_02072020-A00437-32
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Hypothyroidism

Keywords

congenital hypothyroidism; prematurity; screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

  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

  15 days at the time of the second sample

• Effectiveness of the treatment

  at 2 years of age

Study Arms (1)

Premature newborn

Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days)

Biological: Blood test

Interventions

Blood test BIOLOGICAL

routine care blood draw

Premature newborn

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature newborns born in maternity wards included in the study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Chu de Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Congenital Hypothyroidism; Premature Birth

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism; Thyroid Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christine LEFEVRE, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

• Anais GLUSKO-CHARLET, MD

  Arras Hospital Center

  PRINCIPAL INVESTIGATOR

• Sylvie MARIETTE, MD

  Roubaix Hospital Center

  PRINCIPAL INVESTIGATOR

• Pierre TOURNEUX, MD

  Amiens University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine LEFEVRE, MD

CONTACT

03.20.44.50.70; christine.lefevre@chu-lille.fr

Study Design

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

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)