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NCT Number: NCT07625722

Thyroxine Supplementation in Small for Gestational Age (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.

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Key information

Conditions

Thyroid Function Female Urogenital Diseases and Pregnancy Complications Neurodevelopment Outcome Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm SGA and Growth Urogenital Diseases

Age range

2 week–2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

Location contact

Yonghui Yu

CONTACT

[email protected]

+8615168887236

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine Sodium (LT4) Tablets

Drug

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.

Primary outcomes

  1. Cognitive function evaluated by Bayley-IV

    Time frame: At 24 months corrected age

  2. Motor function evaluated by Bayley-IV

    Time frame: At 24 months corrected age

  3. Language function evaluated by Bayley-IV

    Time frame: At 24 months corrected age

  4. Social-Emotional evaluated by Bayley-IV

    Time frame: At 24 months corrected age

  5. Adaptive behavior evaluated by Bayley-IV

    Time frame: At 24 months corrected age

  6. Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.

    Time frame: At 24 months corrected age

  7. Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.

    Time frame: At 24 months corrected age

  8. Weight（kg）assessed by the WHO 0-5 years Child Growth Standards.

    Time frame: At 24 months corrected age

Secondary outcomes

  1. 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

  2. All-cause Mortality

    Time frame: At 24 months corrected age

Study contacts

Contact information is provided by the study sponsor or research team.

Yonghui Yu

CONTACT

[email protected]

+8615168887236

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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