HypothyroxinemiaNCT00565890
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
A study testing thyroxine in people with Hypothyroxinemia, run by Tokyo Women's Medical University at 1 site in Japan.
Trial summary
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted. Read more about this study
- Who is it for?
- Ages 2 to 4 weeks
- Conditions the study is for
- Hypothyroxinemia
- What is being tested?
- thyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2005to Jun 2013
- Phase
- Interventional
- 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 2 to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight: less than 1500g
- Gestation: 22 weeks 0 day ≤
- Serum free thyroxine level lower than 0.8 ng/dl
- Serum thyrotropin lower than 10 μU/ml
- Age of between 2 and 4 weeks after birth
- Informed consent
Who cannot join
- any known thyroid disease in mother
Trial locations and contacts
1 site in 1 country.
Japan1 site
Maternal and Perinatal Center, Tokyo Women's Medical University
Tokyo, Tokyo, 162-8666
About this study
Official title: Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
Read the detailed description
A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.
- Conditions
- Hypothyroxinemia
- Being tested
- thyroxine
- Keywords
- very low birth weight infant, hypothyroxinemia, outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroxineDrug
thyroxine at the dose of 5 μg/kg-wt /day
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | No replacement therapy Receives: Drug: thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor development at 1.5 years of age
Measured: 18 months
Secondary outcomes (4)
Psychomotor development at 3 years of age
Measured: 6 years
Somatic growth at 3 years of age
Measured: 6 years
Duration of hospital stay
Measured: 6 years
Frequency of morbidities during the stay in NICu
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startDec 2005
- Primary completionMar 2011
- Study completionJun 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Women's Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo Metropolitan Bokuto Hospital
- Responsible party
- Principal investigator, Satoshi Kusuda, Tokyo Women's Medical University
- Investigators
- Satoshi Kusuda, MD, Principal investigator, Tokyo Women's Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565890
- Sponsor's protocol ID
- nrntokyo
- Other IDs
- T4VLBWI
- Status last verified
- Jun 2013
- First submitted
- 29 Nov 2007
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
- ClinicalTrials.gov ID
- NCT00565890
- Acronym / sponsor ID
- nrntokyo
- Conditions
- Hypothyroxinemia
- Keywords
- very low birth weight infant, hypothyroxinemia, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tokyo Women's Medical UniversityUniversity, hospital or other
- Collaborators
- Tokyo Metropolitan Bokuto Hospital
- Study start
- Dec 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Nov 2007 (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.
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
Detailed description
A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | Drug: thyroxineNo replacement therapy |
Who may qualify
- Ages
- 2 to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight: less than 1500g
- Gestation: 22 weeks 0 day ≤
- Serum free thyroxine level lower than 0.8 ng/dl
- Serum thyrotropin lower than 10 μU/ml
- Age of between 2 and 4 weeks after birth
Key exclusion criteria (1 listed)
- any known thyroid disease in mother
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 |
|---|---|---|
| thyroxinethyroxine at the dose of 5 μg/kg-wt /day | Drug | 2 |
Primary outcome
Psychomotor development at 1.5 years of age
Time frame: 18 months
4 secondary outcomes
Psychomotor development at 3 years of age
Time frame: 6 years
Somatic growth at 3 years of age
Time frame: 6 years
Duration of hospital stay
Time frame: 6 years
Frequency of morbidities during the stay in NICu
Time frame: 6 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 4 Jun 2013.
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.
Satoshi Kusuda, MD principal investigator
Tokyo Women's Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroxine in people with Hypothyroxinemia, run by Tokyo Women's Medical University at 1 site in Japan.
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 6 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 4 Jun 2013. 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 Japan. 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?
Psychomotor development at 1.5 years of age (time frame: 18 months). 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 4 Jun 2013.