Menu
Not yet recruiting NCT07625722

Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml

No phase Interventional Thyroid Function Preterm SGA and Growth Neurodevelopment Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levothyroxine Sodium (LT4) Tablets.
Who it may be relevant to
Registry conditions: Thyroid Function, Preterm, SGA and Growth, Neurodevelopment Outcome. Basic parameters: 2 Weeks — 2 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Levothyroxine Sodium (LT4) Tablets
    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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan

Identifiers

NCT: NCT07625722 · SWYX：NO.2025-1019-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗