Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage

NCT03390530 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 2017-8707
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Brain bleed in premature infants damages the brain and survivors suffer from cerebral palsy (weakness in the extremities), cognitive deficits, and neurobehavioral disorders. In this clinical trial, investigators will test whether thyroxine (hormone from thyroid gland) treatment in premature infants with moderate-to-large brain bleeds show recovery in the brain structure on MRI evaluation at the time of discharge (44+/-1 weeks) and neurodevelopmental improvement at 2 years of age.

Conditions

Intraventricular Hemorrhage of Prematurity

Keywords

Thyroxine; Intraventricular hemorrhage; MRI with DTI,; Neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• Death or disability

  The primary outcome will be a quantitative composite outcome using the BSID-IV Motor score measured at 22-26 months among survivors while incorporating death using a floor value of 46.

  22-26 months of age

Secondary Outcomes (5)

• BSID-IV Motor subscale

  22-26 months of age

• BSID-IV Cognitive subscale

  22-26 months of age

• BSID-IV Language subscale

  22-26 months of age

• Binary composite outcome of death or moderate/severe NDI

  22-26 months of age

• Cerebral palsy incidence and severity

  22-26 months of age

Other Outcomes (3)

• MRI studies: dMRI measures (fractional anisotropy; radial, axial and mean diffusivity) in the corpus callosum and corticospinal tract

  44+/-1 weeks of postmenstrual age

• MRI studies: myelinated and unmyelinated WM brain volume

  44+/-1 weeks of postmenstrual age

• MRI studies: Kidokoro WM and global scores

  44+/-1 weeks of postmenstrual age

Study Arms (2)

Thyroxine treatment

ACTIVE COMPARATOR

Intravenous thyroxine in a dose of 8 µg/kg/day divided into two doses (every 12 hours)

Drug: Thyroxine

Placebo treatment

PLACEBO COMPARATOR

Intravenous placebo treatment every 12 hours.

Drug: Placebo

Interventions

Thyroxine DRUG

8 µg/kg/day divided into two doses intravenous every 12 hours

Also known as: Levothyroxine

Thyroxine treatment

Placebo DRUG

Placebo

Also known as: Inactive substance in a similarly looking solution

Placebo treatment

Eligibility Criteria

• Age: 3 Days - 6 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• NICU inpatients born between 23-0/7 and 27-6/7 weeks of gestation
• Postnatal age 3-6days (≥3 d ≤ 6 d)
• Unilateral or bilateral Grade 3 or 4 IVH
• Parental consent

You may not qualify if:

• Major malformations, including surgical, cardiac, cerebral, chromosomal, or genetic syndromes, identifiable at or before birth;
• Congenital bacterial infection proven by culture at birth or viral syndrome known prior to delivery (e.g. chicken pox, rubella, etc.)

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Westchester Medical Center: collaborator
• Morgan Stanley Children's Hospital: collaborator
• University of Pittsburgh: collaborator
• Children's Minnesota Hospital: collaborator
• University of Minnesota: collaborator
• St. Louis University: collaborator
• Arkansas Children's Hospital Research Institute: collaborator
• Brigham and Women's Hospital: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Praveen Ballabh

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• PRAVEEN BALLABH, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded and randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Double-blinded, placebo-controlled, and randomized controlled trial to compare outcomes between thyroxine and placebo treatment

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 4, 2018
• Study Start: January 18, 2022
• Primary Completion: December 18, 2025
• Study Completion (Estimated): January 18, 2027
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

US (1)