Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02814383 · ClinicalTrials.gov registry record

Prediction of Brain Injury in Premature Infants

A clinical trial of Intraventricular Hemorrhage and Brain Injury, sponsored by Baylor College of Medicine.

Completed
Registry status
310
Enrollment target
3
Study locations

NCT02814383: Completed study of Intraventricular Hemorrhage and Brain Injury, sponsored by Baylor College of Medicine.

NCT02814383 is a study of Intraventricular Hemorrhage and Brain Injury that has completed, run by Baylor College of Medicine. The registered enrollment target is 310 participants, below the 1,185-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02814383, a study of Intraventricular Hemorrhage and Brain Injury, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
310 participants
Enrollment target
3
Study locations

Study Summary

Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidence is inversely proportional to gestational age (GA) and birth weight (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic hemodynamics during transition from intra- to extra-uterine life and during the early neonatal period is believed to be at their genesis. While the incidence of ultrasound- diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity and brain volume and eventual neurocognitive impairment. Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has remained relatively stable. Once translated to the bedside, the goal of this research is to develop a monitoring system that will allow researchers to identify infants most at risk for IVH and PVL and in the future, intervention studies will be initiated to use the changes in cerebral perfusion to direct hemodynamic management. The purpose of this study is to first understand the physiology of brain injury and then to eventually impact the outcomes in this high-risk group of infants by assessing the ability of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for this study will help develop algorithms or monitoring plans that wi

Primary Outcome

Brain perfusion will be assessed by calculating the diastolic closing margin (DCM). DCM will be measured from continuous recordings of middle cerebral artery cerebral blood flow velocity (CBFV) by transcranial Doppler ultrasound and ABP during first week of life for ELBW infants.

Interventions

  • OTHER Brain Monitoring Platform

Study Locations (3)

Texas

  • Baylor College of Medicine - Houston
  • Texas Children's Hospital - Houston
  • Texas Children's Pavilion for Women - Houston

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2016-08-11
Est. Completion 2025-05-21
Baylor College of Medicine

616 total trials

What the finished NCT02814383 record still lists

NCT02814383 is an observational study that tracks outcomes without assigning an intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 1,185-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (74% lower).

The record links to 4 conditions, with Intraventricular Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Brain Monitoring Platform is the first listed.

NCT02814383 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT02814383 about?

NCT02814383 is a clinical study titled "Prediction of Brain Injury in Premature Infants". Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidenc...

What is the current status of trial NCT02814383?

This trial is currently completed. The enrollment target is 310 participants. The study started on 2016-08-11. Estimated completion is 2025-05-21.

What conditions does trial NCT02814383 study?

This clinical trial studies the following conditions: Intraventricular Hemorrhage, Brain Injury, Extreme Prematurity, Periventricular Leukomalacia.

What interventions are being tested in trial NCT02814383?

The interventions under investigation include: Brain Monitoring Platform (OTHER).

Who is sponsoring clinical trial NCT02814383?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02814383 being conducted?

This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT02814383's enrollment target sits among peer trials

310 7th of 11 higher than 5 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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03039439 · 310 participants

    Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors

  • NCT04178018 · 310 participants · NA

    Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

  • NCT04878094 · 310 participants · Phase 3

    A Study of Intra-operative Imaging in Women With Ovarian Cancer

  • NCT05459233 · 310 participants · NA

    Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02814383, the US trial registry maintained by the National Library of Medicine. NCT02814383 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.