HypothyroxinemiaPhase 3NCT01306227
L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
A Phase 3 study testing L-Thyroxine and water in people with Hypothyroxinemia, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
Trial summary
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial. The purpose of this study is to compare L-thyroxine treatment vs. Read more about this study
- Who is it for?
- Ages 1 week to 5 years
- Conditions the study is for
- Hypothyroxinemia
- What is being tested?
- L-Thyroxine and water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Sep 2006to 31 Dec 2017
- Phase
- Phase 3
- 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 1 week to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 32 WG
- FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL
- TSH (5, 6 or 7 days of life) < 20 mIU/L
- Written consent from the parents
Who cannot join
- Maternal thyroid disease
- FT4 (5, 6 or 7 days of life) > 0.8 ng/dL
- TSH (5, 6 or 7 days of life) > 20 mIU/L
- Grade III or IV intracerebral hemorrhage
Trial locations and contacts
3 sites in 1 country.
France3 sites
Amiens University Hospital
Amiens, Picardie, 80054
Caen University Hospital
Caen, Basse Normandie, 14033
Lens Hospital
Lens, Hauts-de-France, 62307
About this study
Official title: L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.
The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.
The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.
Read the detailed description
Preterm newborns <32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of life. THOP is defined by thyroid-stimulating hormone (TSH) < 20 mIU/L and FT4 < 0.80 ng/dL. After obtaining written consent from the parents, preterm newborns <32 WG with THOP will be included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed 2 weeks after stopping treatment.
The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score.
- Conditions
- Hypothyroxinemia
- Being tested
- L-Thyroxine, water
- Keywords
- Infant, newborn, Infant, preterm, Thyroid, Outcome, Newborns less than 32 weeks of gestation, TSH < 20 mIU/L and a FT4 < 0.80 ng/dL
- Medical subject headings
- Premature Birth, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ThyroxineDrug
Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.
waterDrug
Oral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day.
| Study group | Role | What they receive |
|---|---|---|
| water | Placebo comparator | Oral treatment with water for 6 weeks Receives: Drug: water |
| L-Thyroxine | Experimental | Oral treatment with L-Thyroxine for 6 weeks Receives: Drug: L-Thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcome
Brunet-Lézine score
Measured: 2 years old
Secondary outcomes (1)
Morbidity associated with management of newborns < 32 WG with hypothyroxinemia
- Death
- Bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age)
- Patent ductus arteriosus,
- Shock requiring fluid loading or vasoactive treatments
- Enterocolitis
- Intraventricular hemorrhage
- Retinopathy of prematurity
- Deafness
Measured: discharge, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study start1 Sep 2006
- Primary completion31 Dec 2014
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroxinemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Tourneux, MD, Principal investigator, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306227
- Sponsor's protocol ID
- PHRCIR07-DR-TOURNEUX
- Status last verified
- Aug 2018
- First submitted
- 28 Feb 2011
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT01306227
- Acronym / sponsor ID
- PHRCIR07-DR-TOURNEUX
- Conditions
- Hypothyroxinemia
- Keywords
- Infant, newborn, Infant, preterm, Thyroid, Outcome, Newborns less than 32 weeks of gestation, TSH < 20 mIU/L and a FT4 < 0.80 ng/dL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2006 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Mar 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 associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.
The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.
The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.
Detailed description
Preterm newborns <32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of life. THOP is defined by thyroid-stimulating hormone (TSH) < 20 mIU/L and FT4 < 0.80 ng/dL. After obtaining written consent from the parents, preterm newborns <32 WG with THOP will be included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed 2 weeks after stopping treatment.
The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water | Placebo comparator | Drug: waterOral treatment with water for 6 weeks |
| L-Thyroxine | Experimental | Drug: L-ThyroxineOral treatment with L-Thyroxine for 6 weeks |
Who may qualify
- Ages
- 1 week to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age < 32 WG
- FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL
- TSH (5, 6 or 7 days of life) < 20 mIU/L
- Written consent from the parents
Key exclusion criteria (4 listed)
- Maternal thyroid disease
- FT4 (5, 6 or 7 days of life) > 0.8 ng/dL
- TSH (5, 6 or 7 days of life) > 20 mIU/L
- Grade III or IV intracerebral hemorrhage
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-ThyroxineTreatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day. | Drug | L-Thyroxine |
| waterOral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day. | Drug | water |
Primary outcome
Neurodevelopmental outcome
Time frame: 2 years old
Brunet-Lézine score
1 secondary outcome
Morbidity associated with management of newborns < 32 WG with hypothyroxinemia
Time frame: discharge, 1 year, 2 years
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 10 Aug 2018.
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.
Pierre Tourneux, MD principal investigator
Amiens University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Thyroxine and water in people with Hypothyroxinemia, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 4 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 10 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neurodevelopmental outcome (time frame: 2 years old). 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 10 Aug 2018.