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NCT Number: NCT07425028

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

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.

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Key information

Conditions

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

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Lille

Lille, France

Location contact

Christine LEFEVRE, MD

CONTACT

[email protected]

03.20.44.50.70 Ext.+33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood test

Biological

routine care blood draw

Primary outcomes

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

    Time frame: From birth to Day 15 of life

    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.

Secondary outcomes

  1. Rate of patient negative to congenital hypothyroidism (CH) test

    Time frame: Day 3

  2. Rate of patient positive to congenital hypothyroidism (CH) test

    Time frame: Day 15

  3. persistency of congenital hypothyroidism (CH)

    Time frame: 2 years of age

    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

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

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

    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.

  5. Effectiveness of the treatment

    Time frame: at 2 years of age

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine LEFEVRE, MD

CONTACT

[email protected]

03.20.44.50.70

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PREMATHYRO

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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