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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Cognitive function evaluated by Bayley-IV [Срок оценки: At 24 months corrected age]
• Motor function evaluated by Bayley-IV [Срок оценки: At 24 months corrected age]
• Language function evaluated by Bayley-IV [Срок оценки: At 24 months corrected age]
• Social-Emotional evaluated by Bayley-IV [Срок оценки: At 24 months corrected age]
• Adaptive behavior evaluated by Bayley-IV [Срок оценки: At 24 months corrected age]
• Body length（cm）assessed by the WHO 0-5 years Child Growth Standards. [Срок оценки: At 24 months corrected age]
• Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards. [Срок оценки: At 24 months corrected age]
• Weight（kg）assessed by the WHO 0-5 years Child Growth Standards. [Срок оценки: At 24 months corrected age]

Вторичные конечные точки (2)

• the incidence of neonatal morbidities （EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP）during the initial hospitalization [Срок оценки: at 36 weeks of postmenstrual age]
• All-cause Mortality [Срок оценки: At 24 months corrected age]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Цзинань

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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