Clinical Trials Logo
  1. Home
  2. Prematurity
  3. NCT00817310
  4. Details
NCT00817310 Clinical Trial

Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Prematurity Clinical Trial

Official title:
Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00817310
Other study ID # PEDNE4 ML9999 18185 04550
Secondary ID
Status Completed
Phase N/A
First received January 5, 2009
Last updated December 16, 2013
Start date January 2009
Est. completion date June 2011

Study information
Verified date December 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays.

The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- Birth weight < 1500 grams for all inborn infants and age less than 14 post-natal days

- Birth weight < 1500 grams for all outborn infants transferred to the VCH NICU within the first 72 hours after birth and age less than 14 post-natal days

- Parents agree to their infant's participation and give informed written consent.

Exclusion Criteria:

- Unable to obtain informed consent.

- Congenital brain malformations leading to hydrocephalus

- Genetic and metabolic disorders leading to cerebral pathology

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Monroe Carell Children's Hospital at Vanderbilt, NICU Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary neurodevelopmental outcome BSID III scores 3 years No
See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Completed NCT02273843 - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis Phase 1
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3