Thyroid FunctionNCT07625722
Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
A study testing Levothyroxine Sodium (LT4) Tablets in people with Thyroid Function and Preterm, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth… Read more about this study
- Who is it for?
- Ages 2 to 2 weeks
- Conditions the study is for
- Thyroid Function, Preterm, SGA and Growth
- What is being tested?
- Levothyroxine Sodium (LT4) Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2026to 20 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born Small for Gestational Age (SGA) with a birth weight < 1500g；
- Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；
- Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU/mL；
- Written informed consent obtained from the parents.
Who cannot join
- Diagnosis of Congenital Hypothyroidism (CH) with serum TSH > 20 mIU/mL within the first 2 weeks of life and receiving L-T4 treatment;
- Persistent serum TSH < 6 mIU/mL throughout the first 2 weeks;
- Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;
- Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;
- Presence of major congenital malformations of vital organs or known chromosomal/genetic disorders;
- History of maternal thyroid disease or maternal use of thyroid-related medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Yonghui Yu, +8615168887236, alice20402@126.com
About this study
Official title: Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights < 1500g and TSH levels between 6 and 20 mIU/ml. Preterm infants in the intervention group will receive 8 ug/kg/d of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.
- Conditions
- Thyroid Function, Preterm, SGA and Growth, Neurodevelopment Outcome
- Being tested
- Levothyroxine Sodium (LT4) Tablets
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine Sodium (LT4) TabletsDrug
The intervention group will receive oral levothyroxine (L-T4) initiated on postnatal day 14 at a starting dose of 8 ug/kg/day. Thyroid function will be monitored every 2-4 weeks until 36 weeks postmenstrual age or hospital discharge, with subsequent follow-up at corrected ages of 40 weeks, 3, 6, 12, 18, and 24 months. The L-T4 dosage will be dynamically titrated to achieve therapeutic targets of TSH < 5 mIU/L and FT3/FT4 levels within the upper 50% of the age-specific reference range. Treatment will be discontinued if therapeutic targets are sustained at a dosage below 2 ug/kg/day or if FT3/FT4 levels exceed the upper limit of normal.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| intervention group | Experimental | Not described Receives: Drug: Levothyroxine Sodium (LT4) Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function evaluated by Bayley-IV
Measured: At 24 months corrected age
Motor function evaluated by Bayley-IV
Measured: At 24 months corrected age
Language function evaluated by Bayley-IV
Measured: At 24 months corrected age
Social-Emotional evaluated by Bayley-IV
Measured: At 24 months corrected age
Adaptive behavior evaluated by Bayley-IV
Measured: At 24 months corrected age
Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.
Measured: At 24 months corrected age
Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.
Measured: At 24 months corrected age
Weight（kg）assessed by the WHO 0-5 years Child Growth Standards.
Measured: At 24 months corrected age
Secondary outcomes (2)
the incidence of neonatal morbidities （EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP）during the initial hospitalization
Measured: at 36 weeks of postmenstrual age
All-cause Mortality
Measured: At 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yonghui Yu, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625722
- Sponsor's protocol ID
- SWYX：NO.2025-1019-1
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
- ClinicalTrials.gov ID
- NCT07625722
- Acronym / sponsor ID
- SWYX：NO.2025-1019-1
- Conditions
- Thyroid Function, Preterm, SGA and Growth, Neurodevelopment Outcome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 4 Jun 2026 (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.
The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights < 1500g and TSH levels between 6 and 20 mIU/ml. Preterm infants in the intervention group will receive 8 ug/kg/d of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| intervention group | Experimental | Drug: Levothyroxine Sodium (LT4) Tablets |
Who may qualify
- Ages
- 2 to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born Small for Gestational Age (SGA) with a birth weight < 1500g；
- Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；
- Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU/mL；
- Written informed consent obtained from the parents.
Key exclusion criteria (6 listed)
- Diagnosis of Congenital Hypothyroidism (CH) with serum TSH > 20 mIU/mL within the first 2 weeks of life and receiving L-T4 treatment;
- Persistent serum TSH < 6 mIU/mL throughout the first 2 weeks;
- Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;
- Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;
- Presence of major congenital malformations of vital organs or known chromosomal/genetic disorders;
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 |
|---|---|---|
| Levothyroxine Sodium (LT4) TabletsThe intervention group will receive oral levothyroxine (L-T4) initiated on postnatal day 14 at a starting dose of 8 ug/kg/day. Thyroid function will be monitored every 2-4 weeks until 36 weeks postmenstrual age or hospital discharge, with subsequent follow-up at corrected ages of 40 weeks, 3, 6, 12, 18, and 24 months. The L-T4 dosage will be dynamically titrated to achieve therapeutic targets of TSH < 5 mIU/L and FT3/FT4 levels within the upper 50% of the age-specific reference range. Treatment will be discontinued if therapeutic targets are sustained at a dosage below 2 ug/kg/day or if FT3/FT4 levels exceed the upper limit of normal. | Drug | intervention group |
Primary outcome
Cognitive function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Motor function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Language function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Social-Emotional evaluated by Bayley-IV
Time frame: At 24 months corrected age
Adaptive behavior evaluated by Bayley-IV
Time frame: At 24 months corrected age
Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
Weight（kg）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
2 secondary outcomes
the incidence of neonatal morbidities （EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP）during the initial hospitalization
Time frame: at 36 weeks of postmenstrual age
All-cause Mortality
Time frame: At 24 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine Sodium (LT4) Tablets in people with Thyroid Function and Preterm, run by Shandong Provincial Hospital at 1 site in China.
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 6 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Yu (+8615168887236, alice20402@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function evaluated by Bayley-IV (time frame: At 24 months corrected age). The study lists 8 primary outcomes in all. 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 2026.