Thyroid MetabolismNCT01466023
The Reduced Thyroid Function of the Premature Newborn: Relation With Molecular Changes in the Placenta and Maternal Thyroid Hormone Status and Neurodevelopmental Implications
An observational study of Thyroid Metabolism, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant, affecting the majority of preterm infants, born less than 30 weeks of gestational age. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Metabolism
- How many people
- 319 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in a tertiairy hospital
Who may be able to join
- pregnant
- at risk of preterm delivery
Who cannot join
- known congenital abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant, affecting the majority of preterm infants, born less than 30 weeks of gestational age. It is defined as a temporary postnatal reduction from cord values in serum levels of T4 and FT4, but with normal thyroid-stimulating hormone (TSH) levels.The etiology of THOP is complex and multifactorial. Loss of maternal T4, limited postnatal thermogenesis, hypothalamic-pituitary immaturity, limited thyroid gland reserve, persistent fetal thyroid hormone metabolism and predisposition to nonthyroidal illness syndrome are several factors that contribute in less or more intensity to THOP.The association between THOP and poor neurodevelopmental outcome is well established and several therapeutic clinical trials have been set up. However, there is currently no evidence for prophylactic or therapeutic supplementation with thyroxine (T4) for premature infants with THOP. One study of van Wassenaer et al. showed a beneficial effect of treatment of THOP in a subgroup of preterm infants with gestational age less than 28 weeks, but a reverse effect in the group with a gestational age of 29 weeks. This is an illustration of the limited comprehension of the pathophysiology of THOP.
Although studies about THOP usually involves the preterm infants born at 33 weeks or earlier, one study of Paul et al. showed a decreased thyroid function in late preterm and term infants with respiratory distress syndrome as function of severity of illness. Unpublished data of our center showed also the presence of THOP, although less frequent, in the group of late preterm infants. Other data about this group of preterm infants are scarce.
Read more
During the first half of pregnancy, the fetus is completely dependent of maternal thyroid hormone supply and the fetal thyroid gland starts thyroid hormone secretion from about 17-19 weeks of gestational age. Conditions of maternal (sub)clinical hypothyroidism are associated with complications like hypertension, preterm birth, low birth weight, placental abruption, and fetal death. One can wonder if there are compensating mechanisms in the placenta, providing the fetus with sufficient thyroid hormone in cases of compromised thyroid supply. One study showed that total placenta deiodinase type 3 (D3) activity in pregnancies with severely hypothyroid fetuses was not significantly lower than in euthyroid controls. Two studies showed increased monocarboxylate transporter 8 (MCT8) and decreased MCT10 expression within placentae of pregnancies complicated by IUGR. As far as we know, nothing is known about possible compensating effects in placentae of mothers with subclinical hypothyroidism and the possible influence on the development of THOP.
Maternal subclinical hypothyroidism during pregnancy is a predisposition for the development of overt hypothyroidism. The influence of maternal thyroid antibodies during pregnancy towards thyroid hormone function of the fetus and consequently neurodevelopmental outcome is still not clear. One single study of Negro et al. showed that euthyroid pregnant women who are positive for thyroid peroxidase antibodies (TPOAb) develop impaired thyroid function, which is associated with an increased risk of miscarriage and premature deliveries. They also showed that substitutive treatment with levothyroxine (LT4) is able to lower the chance of miscarriage and premature delivery.A study of Pop et al. concluded that children of pregnant women who had elevated titers of TPO-Ab but normal thyroid function are at risk for impaired development.Nothing is known about the possible influence of maternal thyroid antibodies towards the development of THOP, although a theoretical link is possible.
The investigators want to investigate whether there are compensatory mechanisms in placentas of premature born infants and whether the maternal thyroid hormone condition is a prediction of the development of THOP in the premature infant. The investigators want to investigate the differences between several groups of preterm infants: 24-28 weeks, 28-32 weeks and 32-36 weeks. The further aim of this study is to investigate the impact of maternal thyroid hormone condition during pregnancy on neurodevelopmental outcome of the neonate.
In Belgium, 8% of the newborns are born preterm. There are about 2000 deliveries each year in the University Hospitals Leuven. Between 2 and 5% of all pregnant women are considered to have subclinical hypothyroidism and preterm birth is almost 2-fold higher in women with subclinical hypothyroidism.The incidence of THOP is 30 %. We performed a statistical power calculation with a confidence level of 95%. Given the above data and with the assumption that 50% of the premature babies born to a hypothyroid mothers will develop THOP, we need to include 320 patients who give premature birth to obtain a statistical power of 80%. Therefore, the inclusion time will be 2 years.
- Conditions
- Thyroid Metabolism
- Keywords
- thyroid metabolism during pregnancy, impact on neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid MetabolismStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466023
- Sponsor's protocol ID
- S53423
- Status last verified
- Jul 2011
- First submitted
- 2 Nov 2011
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reduced Thyroid Function of the Premature Newborn: Relation With Molecular Changes in the Placenta and Maternal Thyroid Hormone Status and Neurodevelopmental Implications
- ClinicalTrials.gov ID
- NCT01466023
- Acronym / sponsor ID
- S53423
- Conditions
- Thyroid Metabolism
- Keywords
- thyroid metabolism during pregnancy, impact on neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant, affecting the majority of preterm infants, born less than 30 weeks of gestational age. It is defined as a temporary postnatal reduction from cord values in serum levels of T4 and FT4, but with normal thyroid-stimulating hormone (TSH) levels.The etiology of THOP is complex and multifactorial. Loss of maternal T4, limited postnatal thermogenesis, hypothalamic-pituitary immaturity, limited thyroid gland reserve, persistent fetal thyroid hormone metabolism and predisposition to nonthyroidal illness syndrome are several factors that contribute in less or more intensity to THOP.The association between THOP and poor neurodevelopmental outcome is well established and several therapeutic clinical trials have been set up. However, there is currently no evidence for prophylactic or therapeutic supplementation with thyroxine (T4) for premature infants with THOP. One study of van Wassenaer et al. showed a beneficial effect of treatment of THOP in a subgroup of preterm infants with gestational age less than 28 weeks, but a reverse effect in the group with a gestational age of 29 weeks. This is an illustration of the limited comprehension of the pathophysiology of THOP.
Although studies about THOP usually involves the preterm infants born at 33 weeks or earlier, one study of Paul et al. showed a decreased thyroid function in late preterm and term infants with respiratory distress syndrome as function of severity of illness. Unpublished data of our center showed also the presence of THOP, although less frequent, in the group of late preterm infants. Other data about this group of preterm infants are scarce.
During the first half of pregnancy, the fetus is completely dependent of maternal thyroid hormone supply and the fetal thyroid gland starts thyroid hormone secretion from about 17-19 weeks of gestational age. Conditions of maternal (sub)clinical hypothyroidism are associated with complications like hypertension, preterm birth, low birth weight, placental abruption, and fetal death. One can wonder if there are compensating mechanisms in the placenta, providing the fetus with sufficient thyroid hormone in cases of compromised thyroid supply. One study showed that total placenta deiodinase type 3 (D3) activity in pregnancies with severely hypothyroid fetuses was not significantly lower than in euthyroid controls. Two studies showed increased monocarboxylate transporter 8 (MCT8) and decreased MCT10 expression within placentae of pregnancies complicated by IUGR. As far as we know, nothing is known about possible compensating effects in placentae of mothers with subclinical hypothyroidism and the possible influence on the development of THOP.
Maternal subclinical hypothyroidism during pregnancy is a predisposition for the development of overt hypothyroidism. The influence of maternal thyroid antibodies during pregnancy towards thyroid hormone function of the fetus and consequently neurodevelopmental outcome is still not clear. One single study of Negro et al. showed that euthyroid pregnant women who are positive for thyroid peroxidase antibodies (TPOAb) develop impaired thyroid function, which is associated with an increased risk of miscarriage and premature deliveries. They also showed that substitutive treatment with levothyroxine (LT4) is able to lower the chance of miscarriage and premature delivery.A study of Pop et al. concluded that children of pregnant women who had elevated titers of TPO-Ab but normal thyroid function are at risk for impaired development.Nothing is known about the possible influence of maternal thyroid antibodies towards the development of THOP, although a theoretical link is possible.
The investigators want to investigate whether there are compensatory mechanisms in placentas of premature born infants and whether the maternal thyroid hormone condition is a prediction of the development of THOP in the premature infant. The investigators want to investigate the differences between several groups of preterm infants: 24-28 weeks, 28-32 weeks and 32-36 weeks. The further aim of this study is to investigate the impact of maternal thyroid hormone condition during pregnancy on neurodevelopmental outcome of the neonate.
In Belgium, 8% of the newborns are born preterm. There are about 2000 deliveries each year in the University Hospitals Leuven. Between 2 and 5% of all pregnant women are considered to have subclinical hypothyroidism and preterm birth is almost 2-fold higher in women with subclinical hypothyroidism.The incidence of THOP is 30 %. We performed a statistical power calculation with a confidence level of 95%. Given the above data and with the assumption that 50% of the premature babies born to a hypothyroid mothers will develop THOP, we need to include 320 patients who give premature birth to obtain a statistical power of 80%. Therefore, the inclusion time will be 2 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in a tertiairy hospital
Key inclusion criteria (2 listed)
- pregnant
- at risk of preterm delivery
Key exclusion criteria (1 listed)
- known congenital abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Related trials for Thyroid Metabolism
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Metabolism, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.