Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and… (NCT07625722) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
China106 participantsStarted 2026-06-20
Plain-language 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 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.
Who can participate
Age range
2 Weeks – 2 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive function evaluated by Bayley-IV
Timeframe: At 24 months corrected age
2
Motor function evaluated by Bayley-IV
Timeframe: At 24 months corrected age
3
Language function evaluated by Bayley-IV
Timeframe: At 24 months corrected age
4
Social-Emotional evaluated by Bayley-IV
Timeframe: At 24 months corrected age
5
Adaptive behavior evaluated by Bayley-IV
Timeframe: At 24 months corrected age
6
Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.
Timeframe: At 24 months corrected age
7
Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.