NCT00565890

Brief Summary

In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5.2 years

First QC Date

November 29, 2007

Last Update Submit

June 3, 2013

Conditions

Hypothyroxinemia

Keywords

very low birth weight infanthypothyroxinemiaoutcomes

Outcome Measures

Primary Outcomes (1)

  • Psychomotor development at 1.5 years of age

    18 months

Secondary Outcomes (4)

  • Psychomotor development at 3 years of age

    6 years

  • Somatic growth at 3 years of age

    6 years

  • Duration of hospital stay

    6 years

  • Frequency of morbidities during the stay in NICu

    6 years

Study Arms (1)

2

NO INTERVENTION

No replacement therapy

Drug: thyroxine

Interventions

thyroxineDRUG

thyroxine at the dose of 5 μg/kg-wt /day

2

Eligibility Criteria

Age2 Weeks - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight: less than 1500g
  • Gestation: 22 weeks 0 day ≤
  • Serum free thyroxine level lower than 0.8 ng/dl
  • Serum thyrotropin lower than 10 μU/ml
  • Age of between 2 and 4 weeks after birth
  • Informed consent

You may not qualify if:

  • any known thyroid disease in mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Perinatal Center, Tokyo Women's Medical University

Tokyo, Tokyo, 162-8666, Japan

Location

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Satoshi Kusuda, MD

    Tokyo Women's Medical Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

December 1, 2005

Primary Completion

March 1, 2011

Study Completion

June 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

JP(1)