Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia - Tabular View

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

November 29, 2007

Start Date ^ICMJE

December 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Official Title ^ICMJE

Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-Low-Birth-Weight Infants With Hypothyroxinemia During the First Month of Age

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypothyroxinemia

Intervention ^ICMJE

Drug: thyroxine

Study Arms / Comparison Groups

No Intervention: No replacement therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 4 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Satoshi Kusuda, MD	03-5269-7344	skusuda@boshi.twmu.ac.jp
Contact: Atsushi Uchiyama, MD	03-3353-8111 ext 28862	auchiyama12@nifty.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00565890

Responsible Party

Hiroshi Nishida/Director, Tokyo Women's Medical University, Maternal and Perinatal Center

Study ID Numbers ^ICMJE

nrntokyo, T4VLBWI

Study Sponsor ^ICMJE

Tokyo Women's Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Satoshi Kusuda, MD

Tokyo Women's Medical Unversity

Information Provided By

Tokyo Women's Medical University

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP