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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-2
SponsorShandong Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: intervention groupExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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