Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

This study is ongoing, but not recruiting participants.

First Received on November 29, 2007. Last Updated on December 3, 2011 History of Changes

Sponsor:	Tokyo Women's Medical University
Collaborator:	Tokyo Metropolitan Bokuto Hospital
Information provided by (Responsible Party):	Satoshi Kusuda, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:	NCT00565890

Purpose

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	Intervention
Hypothyroxinemia	Drug: thyroxine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

Drug Information available for: Thyroxine Levothyroxine Sodium Levothroid

U.S. FDA Resources

Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:

Psychomotor development at 1.5 years of age [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psychomotor development at 3 years of age [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
Somatic growth at 3 years of age [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
Duration of hospital stay [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
Frequency of morbidities during the stay in NICu [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 2 No replacement therapy	Drug: thyroxine thyroxine at the dose of 5 μg/kg-wt /day

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.

Eligibility

Ages Eligible for Study:	up to 4 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565890

Locations

Japan
Maternal and Perinatal Center, Tokyo Women's Medical University
Tokyo, Japan, 162-8666

Sponsors and Collaborators

Tokyo Women's Medical University

Tokyo Metropolitan Bokuto Hospital

Investigators

Principal Investigator:

Satoshi Kusuda, MD

Tokyo Women's Medical Unversity

More Information

No publications provided

Responsible Party:	Satoshi Kusuda, Director, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:	NCT00565890 History of Changes
Other Study ID Numbers:	nrntokyo, T4VLBWI
Study First Received:	November 29, 2007
Last Updated:	December 3, 2011
Health Authority:	Japan: Institutional Review Board

Keywords provided by Tokyo Women's Medical University:

very low birth weight infant
hypothyroxinemia
outcomes

ClinicalTrials.gov processed this record on February 09, 2012