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)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 90
• Patients Per Site Per Month: 1.1

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 Disease	Intervention/Treatment	Phase
Hypothyroxinemia	Drug: thyroxine	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

Arm	Intervention/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: 2 Weeks 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

	Site	City	State	Country	Postal Code
1	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

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: very low birth weight infant; hypothyroxinemia; outcomes
• Additional relevant MeSH terms: Birth Weight

Study Results

No Results Posted as of Jun 4, 2013