Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Sponsor
Tokyo Women's Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT00565890
Collaborator
Tokyo Metropolitan Bokuto Hospital (Other)
100
Enrollment
1
Location
1
Arm
90
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Detailed Description

A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

ArmIntervention/Treatment
No Intervention: 2

No replacement therapy

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

Outcome Measures

Primary Outcome Measures

  1. Psychomotor development at 1.5 years of age [18 months]

Secondary Outcome Measures

  1. Psychomotor development at 3 years of age [6 years]

  2. Somatic growth at 3 years of age [6 years]

  3. Duration of hospital stay [6 years]

  4. Frequency of morbidities during the stay in NICu [6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 4 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • any known thyroid disease in mother

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Maternal and Perinatal Center, Tokyo Women's Medical UniversityTokyoJapan162-8666

Sponsors and Collaborators

  • Tokyo Women's Medical University
  • Tokyo Metropolitan Bokuto Hospital

Investigators

  • Principal Investigator: Satoshi Kusuda, MD, Tokyo Women's Medical Unversity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Satoshi Kusuda, Director, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT00565890
Other Study ID Numbers:
  • nrntokyo
  • T4VLBWI
First Posted:
Nov 30, 2007
Last Update Posted:
Jun 4, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Satoshi Kusuda, Director, Tokyo Women's Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2013