Transient Hypothyroxinemia of PrematurityNEO-TYRNCT06346236
Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.
An observational study of Transient Hypothyroxinemia of Prematurity, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Read more about this study
- Who is it for?
- Ages Up to 2 weeks
- Conditions the study is for
- Transient Hypothyroxinemia of Prematurity
- What is being tested?
- L-thyroxine at a dose of 7.5 µg/kg/d for THOP, THOP without treatment and NoTHOP
- How many people
- 373 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2020to 1 Sep 2022
- 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 Up to 2 weeks
- All sexes
- Child
Study population: Reanimation and intensive care units of neonatology in Auvergne-Rhone Alpes region (Lyon Croix Rousse hospital, Lyon Femme mère Enfant hospital, St Etienne Hopital Nord, Grenoble Hopital couple enfant).
Who may be able to join
- Premature infants born before or at 3032 weeks of gestation
- For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.
Who cannot join
- Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
- Associated polymalformative sindrome
Trial locations and contacts
3 sites in 1 country.
France3 sites
HFME
Bron, 69300
CHU Grenoble
Grenoble, 38100
CHU Saint EtienneHopital
Saint-Etienne, 42000
About this study
Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.
In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 < 12 pmol/L and a level of TSH < 15 mUI/L before 15 days of life or < 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.
- Being tested
- L-thyroxine at a dose of 7.5 µg/kg/d for THOP, THOP without treatment, NoTHOP
- Keywords
- transient hypothyroxinaemia of prematurity, THOP, preterm, prematurity, neurodevelopment, L-thyroxine, ASQ score
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-thyroxine at a dose of 7.5 µg/kg/d for THOPDrug
Subjects diagnosed with THOP (as previously defined) and treated with L-thyroxine at a dose of 7.5 µg/kg/d are less likely to have an impaired ASQ score at 4 years of corrected age.
THOP without treatmentOther
Subjects diagnosed with THOP (as previously defined) and who received no L-thyroxine treatment.
NoTHOPOther
Subjects diagnosed no-THOP (as previously defined)
| Study group | Role | What they receive |
|---|---|---|
| THOP treated | Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone < 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR < 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration) Receives: Drug: L-thyroxine at a dose of 7.5 µg/kg/d for THOP | |
| THOP un-treated | Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone < 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR < 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record. Receives: Other: THOP without treatment | |
| No-THOP | all level of circulating T4 > 12 pmol/L at any time in life Receives: Other: NoTHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.
Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.
Measured: Evaluation at two years of corrected age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Mar 2020
- Primary completion1 Jul 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Hypothyroxinemia of PrematurityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346236
- Sponsor's protocol ID
- 69HCL21_0843
- Other IDs
- 401
- Acronym
- NEO-TYR
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.
- ClinicalTrials.gov ID
- NCT06346236
- Acronym / sponsor ID
- NEO-TYR / 69HCL21_0843
- Keywords
- transient hypothyroxinaemia of prematurity, THOP, preterm, prematurity, neurodevelopment, L-thyroxine, ASQ score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 3 Apr 2024 (actual)
- 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.
Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.
In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 < 12 pmol/L and a level of TSH < 15 mUI/L before 15 days of life or < 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THOP treated | – | Drug: L-thyroxine at a dose of 7.5 µg/kg/d for THOPLevel of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone < 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR < 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration) |
| THOP un-treated | – | Other: THOP without treatmentLevel of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone < 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR < 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record. |
| No-THOP | – | Other: NoTHOPall level of circulating T4 > 12 pmol/L at any time in life |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Reanimation and intensive care units of neonatology in Auvergne-Rhone Alpes region (Lyon Croix Rousse hospital, Lyon Femme mère Enfant hospital, St Etienne Hopital Nord, Grenoble Hopital couple enfant).
Key inclusion criteria (2 listed)
- Premature infants born before or at 3032 weeks of gestation
- For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.
Key exclusion criteria (2 listed)
- Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
- Associated polymalformative sindrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-thyroxine at a dose of 7.5 µg/kg/d for THOPSubjects diagnosed with THOP (as previously defined) and treated with L-thyroxine at a dose of 7.5 µg/kg/d are less likely to have an impaired ASQ score at 4 years of corrected age. | Drug | THOP treated |
| THOP without treatmentSubjects diagnosed with THOP (as previously defined) and who received no L-thyroxine treatment. | Other | THOP un-treated |
| NoTHOPSubjects diagnosed no-THOP (as previously defined) | Other | No-THOP |
Primary outcome
Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.
Time frame: Evaluation at two years of corrected age.
Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.
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 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Hypothyroxinemia of Prematurity, run by Hospices Civils de Lyon at 3 sites in France.
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 2 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does the primary outcome measure?
Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation. (time frame: Evaluation at two years of corrected age.). It is what the study was designed to measure, not a finding.
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 Apr 2024.