Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants
Completed · Not applicable
Conditions studied: Intraventricular Hemorrhage, Hydrocephalus
In brief
Intraventricular hemorrhage remains the most frequent, severe neurological complication of prematurity, occurring in 25-30% of preterm infants. Post-hemorrhagic ventricular dilation (PHVD) occurs in 25-50% of those infants, with over half requiring ventriculoperitoneal shunts. When suboptimally untreated, PVHD results in a 3-4 fold increase in neurodevelopmental delay. Despite the lifelong impact of PHVD on quality of life, little research has been done over the past 20 years to improve patient outcomes. The CENTRAL HYPOTHESIS of this project is that early treatment of PHVD will reduce shunt-dependence and improve neurodevelopmental outcome in preterm infants.
Key facts
- Study ID
- NCT00875758
- Run by
- Washington University School of Medicine
- People needed
- 7
- Starts
- 2009-05-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2017-11-06
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants born at ≤ 34 weeks estimated gestational age with ultrasound-confirmed IVH will be followed for eligibility.
- All infants with any grade IVH will be carefully followed with serial ultrasounds 1-3 times weekly to monitor ventricular measures.
- All infants with any grade IVH will be carefully followed for their ventricular measures. If ventricular measures are crossing percentile lines toward the 90th then the infant will be considered for recruitment as soon as the measures cross 97th.
You may not qualify if…
- Infants with congenital cerebral malformations
- Cystic periventricular leukomalacia
- CNS infection, metabolic disease
- PHVD present at birth will be excluded from the study.
Where it is running
- St. Louis Children's Hospital — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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