Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia - Full Text View

Sponsored by:	Tokyo Women's Medical University
Information provided by:	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

Drug Information available for: Levothyroxine Sodium Thyroxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-Low-Birth-Weight Infants With Hypothyroxinemia During the First Month of Age

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:	January 2010

Arms	Assigned Interventions
2: No Intervention 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

Contacts

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

Locations

Japan
Maternal and Perinatal Center, Tokyo Women's Medical University	Recruiting
Tokyo, Japan, 162-8666
Contact: Satoshi Kusuda, MD 03-5269-7344 skusuda@boshi.twmu.ac.jp
Principal Investigator: Satoshi Kusuda, MD

Sponsors and Collaborators

Tokyo Women's Medical University

Investigators

Principal Investigator:

Satoshi Kusuda, MD

Tokyo Women's Medical Unversity

More Information

Responsible Party:	Maternal and Perinatal Center ( Hiroshi Nishida/Director, Tokyo Women's Medical University )
Study ID Numbers:	nrntokyo, T4VLBWI
Study First Received:	November 29, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00565890
Health Authority:	Japan: Institutional Review Board

Keywords provided by Tokyo Women's Medical University:

very low birth weight infant
hypothyroxinemia
outcomes

Study placed in the following topic categories:

Body Weight
Birth Weight

ClinicalTrials.gov processed this record on January 15, 2009