Intraventricular Hemorrhage of PrematurityPhase 3IVHT4NCT03390530
Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage
A Phase 3 study testing Thyroxine in people with Intraventricular Hemorrhage of Prematurity, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 days
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity
- What is being tested?
- Thyroxine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 18 Jan 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage: Phase III Clinical Trial
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.
Read the detailed description
Intraventricular hemorrhage (IVH) remains a major complication of prematurely born infants. Survivors of IVH suffer from cerebral palsy, cognitive deficits and neurobehavioral disorders. In the proposed study We hypothesize that T4 treatment in preterm (230/7-276/7 weeks) infants with grade II-IV IVH will: a) improve MRI biomarkers, including total myelinated white matter volume, Kidokoro scoring, functional connectivity between motor brain regions, and fractional anisotropy in the corpus callosum of preterm infants with grade II-IV IVH at 36 weeks postmenstrual age, and b) better composite outcome of disability and death. The composite outcome will be derived by integrating scores for Bayley Scales of Infant and Toddler Development (BSID-IV) Motor subscale at 22-26 months in survivors and BSID IV value of 46 assigned to deceased infants. To test these hypotheses, we will perform a randomized double-blinded placebo-controlled trial to determine the effect of T4 treatment on preterm infants with grade II-IV IVH. Ten participating neonatal intensive care units will enroll 346 premature infants (230/7-276/7 weeks gestational age. 173 in each arm) with unilateral or bilateral grade II-IV IVH over a period of 3 years. The treatment will consist of T4 administration (8 µg/kg/day divided into two doses) up to 34 weeks of postmenstrual age, which will be initiated at 2-5 days of postnatal age in all cases. The infants will undergo MRI with DTI at 36 weeks and neurobehavioral evaluation at 22-26 months of corrected age. We have assumed a 7.5 point mean difference (SD=15) in BSID-IV motor subscale between T4 and placebo groups, an overall mortality rate of 25%, and 5% reduction in mortality for each SD change in outcome. Based on these, we expect an increase in the induced composite outcome by ≥5.6 points in T4 treated group compared to placebo controls. The study will conclusively determine whether the proposed clinical trial of T4 treatment enhances motor outcome and diminishes composite endpoint of death or disability in preterm infants with grade II-IV IVH.
- Being tested
- Thyroxine, Placebo
- Keywords
- Thyroxine, Intraventricular hemorrhage, MRI with DTI,, Neurodevelopmental outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroxineDrug
Also called Levothyroxine
8 µg/kg/day divided into two doses intravenous every 12 hours
PlaceboDrug
Also called Inactive substance in a similarly looking solution
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Thyroxine treatment | Active comparator | Intravenous thyroxine in a dose of 8 µg/kg/day divided into two doses (every 12 hours) Receives: Drug: Thyroxine |
| Placebo treatment | Placebo comparator | Intravenous placebo treatment every 12 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22-26 months of age
Secondary outcomes (5)
BSID-IV Motor subscale
Bayley Scales of Infant and Toddler Development (BSID) IV score.
Measured: 22-26 months of age
BSID-IV Cognitive subscale
Bayley Scales of Infant and Toddler Development (BSID) IV score.
Measured: 22-26 months of age
BSID-IV Language subscale
Bayley Scales of Infant and Toddler Development (BSID) IV score.
Measured: 22-26 months of age
Binary composite outcome of death or moderate/severe NDI
NDI will be defined as the presence of any of the following: BSID-IV Cognitive < 85, BSID-IV Motor <85, GMFCS ≥ 2 (NICHD, Neonatal Res. Network 2018)
Measured: 22-26 months of age
Cerebral palsy incidence and severity
We will perform neurological examination as in PENUT study and GMFCS scoring to determine cerebral palsy incidence and severity
Measured: 22-26 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start18 Jan 2022 (estimated)
- Primary completion18 Dec 2025 (estimated)
- Study completion18 Jan 2027 (estimated)
Why it stopped: Closed by PI prior to approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, placebo-controlled, and randomized controlled trial to compare outcomes between thyroxine and placebo treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Westchester Medical Center, Morgan Stanley Children's Hospital, University of Pittsburgh, Children's Hospitals and Clinics of Minnesota, University of Minnesota, St. Louis University, Arkansas Children's Hospital Research Institute, Brigham and Women's Hospital, University of North Carolina, Chapel Hill, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Praveen Ballabh, Albert Einstein College of Medicine
- Investigators
- PRAVEEN BALLABH, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390530
- Sponsor's protocol ID
- 2017-8707
- Acronym
- IVHT4
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2017
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage: Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT03390530
- Acronym / sponsor ID
- IVHT4 / 2017-8707
- Keywords
- Thyroxine, Intraventricular hemorrhage, MRI with DTI,, Neurodevelopmental outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed by PI prior to approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Westchester Medical Center, Morgan Stanley Children's Hospital, University of Pittsburgh, Children's Hospitals and Clinics of Minnesota, University of Minnesota, St. Louis University, Arkansas Children's Hospital Research Institute, Brigham and Women's Hospital, University of North Carolina, Chapel Hill, Wake Forest University Health Sciences
- Study start
- 18 Jan 2022 (estimated)
- Primary completion
- 18 Dec 2025 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intraventricular hemorrhage (IVH) remains a major complication of prematurely born infants. Survivors of IVH suffer from cerebral palsy, cognitive deficits and neurobehavioral disorders. In the proposed study We hypothesize that T4 treatment in preterm (230/7-276/7 weeks) infants with grade II-IV IVH will: a) improve MRI biomarkers, including total myelinated white matter volume, Kidokoro scoring, functional connectivity between motor brain regions, and fractional anisotropy in the corpus callosum of preterm infants with grade II-IV IVH at 36 weeks postmenstrual age, and b) better composite outcome of disability and death. The composite outcome will be derived by integrating scores for Bayley Scales of Infant and Toddler Development (BSID-IV) Motor subscale at 22-26 months in survivors and BSID IV value of 46 assigned to deceased infants. To test these hypotheses, we will perform a randomized double-blinded placebo-controlled trial to determine the effect of T4 treatment on preterm infants with grade II-IV IVH. Ten participating neonatal intensive care units will enroll 346 premature infants (230/7-276/7 weeks gestational age. 173 in each arm) with unilateral or bilateral grade II-IV IVH over a period of 3 years. The treatment will consist of T4 administration (8 µg/kg/day divided into two doses) up to 34 weeks of postmenstrual age, which will be initiated at 2-5 days of postnatal age in all cases. The infants will undergo MRI with DTI at 36 weeks and neurobehavioral evaluation at 22-26 months of corrected age. We have assumed a 7.5 point mean difference (SD=15) in BSID-IV motor subscale between T4 and placebo groups, an overall mortality rate of 25%, and 5% reduction in mortality for each SD change in outcome. Based on these, we expect an increase in the induced composite outcome by ≥5.6 points in T4 treated group compared to placebo controls. The study will conclusively determine whether the proposed clinical trial of T4 treatment enhances motor outcome and diminishes composite endpoint of death or disability in preterm infants with grade II-IV IVH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, placebo-controlled, and randomized controlled trial to compare outcomes between thyroxine and placebo treatment
| Arm | Type | Receives |
|---|---|---|
| Thyroxine treatment | Active comparator | Drug: ThyroxineIntravenous thyroxine in a dose of 8 µg/kg/day divided into two doses (every 12 hours) |
| Placebo treatment | Placebo comparator | Drug: PlaceboIntravenous placebo treatment every 12 hours. |
Who may qualify
- Ages
- 3 to 6 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThyroxineAlso: Levothyroxine8 µg/kg/day divided into two doses intravenous every 12 hours | Drug | Thyroxine treatment |
| PlaceboAlso: Inactive substance in a similarly looking solutionPlacebo | Drug | Placebo treatment |
Primary outcome
Death or disability
Time frame: 22-26 months of age
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.
5 secondary outcomes
BSID-IV Motor subscale
Time frame: 22-26 months of age
BSID-IV Cognitive subscale
Time frame: 22-26 months of age
BSID-IV Language subscale
Time frame: 22-26 months of age
Binary composite outcome of death or moderate/severe NDI
Time frame: 22-26 months of age
Cerebral palsy incidence and severity
Time frame: 22-26 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PRAVEEN BALLABH, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thyroxine in people with Intraventricular Hemorrhage of Prematurity, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or disability (time frame: 22-26 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.