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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age23-32
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Premature newborns born in maternity wards included in the study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Biological/Vaccine

    routine care blood draw

Treatment groups

1,600 Participants
are divided into 1 treatment group
Group A: Premature newborn1 intervention

Trial outcomes

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.

Time frame
From birth to Day 15 of life

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)

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
4

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

Other outcomes

Sponsors and contacts

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