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NCT02221219 · ClinicalTrials.gov registry record · Phase 1
Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
A Phase 1 study of Intraventricular Hemorrhage and Brain Injury, sponsored by Hong Huang.
- Completed
- Registry status
- Phase 1
- Development phase
- 256
- Enrollment target
- 1
- Study location
NCT02221219: Completed Phase 1 study of Intraventricular Hemorrhage and Brain Injury, sponsored by Hong Huang.
NCT02221219 is a Phase 1 study of Intraventricular Hemorrhage and Brain Injury that has completed, run by Hong Huang. The registered enrollment target is 256 participants, below the 1,190-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02221219, a Phase 1 study of Intraventricular Hemorrhage and Brain Injury, has completed, sponsored by Hong Huang.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 256 participants
- Enrollment target
- 1
- Study location
Study Summary
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.
Primary Outcome
determined by head ultrasound in Neonatal Intensive Care Unit (NICU) and single head MRI at 38weeks corrected gestational age
Conditions Studied
Interventions
- DRUG Indomethacin
- DRUG placebo infusion
- PROCEDURE delay in umbilical cord clamp at birth
- PROCEDURE immediate cord clamp at birth
Study Locations (1)
Kentucky
- Kentucky Childrens Hospital Neonatal Intensive Care Unit - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2014-08 |
| Est. Completion | 2021-08-28 |
| Phase | Phase 1 |
What the finished NCT02221219 record still lists
NCT02221219 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 1,190-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Intraventricular Hemorrhage appearing as the primary indexed condition, and to 4 interventions - of which Indomethacin is the first listed.
NCT02221219 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT02221219 about?
NCT02221219 is a clinical study titled "Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury". Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous ...
What is the current status of trial NCT02221219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 256 participants. The study started on 2014-08. Estimated completion is 2021-08-28.
What conditions does trial NCT02221219 study?
This clinical trial studies the following conditions: Intraventricular Hemorrhage, Brain Injury, Periventricular Leukomalacia, Renal Injury.
What interventions are being tested in trial NCT02221219?
The interventions under investigation include: Indomethacin (DRUG), placebo infusion (DRUG), delay in umbilical cord clamp at birth (PROCEDURE), immediate cord clamp at birth (PROCEDURE).
Who is sponsoring clinical trial NCT02221219?
This trial is sponsored by Hong Huang, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02221219 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Intraventricular Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02221219's enrollment target sits among peer trials
256 8th of 11 higher than 4 of 11 other Intraventricular Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intraventricular Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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