NCT00875758|CompletedDMC
Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants
LETAP
Phase II Study of Late- Versus Early Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants.
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LETAP
Phase II Study of Late- Versus Early Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants.
Sponsor study identifier
interventional
7
1 country
1
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2009
Actual (reported)April 3, 2009
Actual (reported)May 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 2013
Actual (reported)November 2013
Actual (reported)Ventriculoperitoneal shunt-dependence
One year
Shunt malfunction
4 years
Unnecessary device implantation
One year
Shunt infection
One year
Neurodevelopmental Outcome
18-24 months of age
Ventricular access devices (VADs) are surgically implanted when cranial ultrasound measures reach treatment group-specific criteria. For the standard-threshold arm, VADs will be implanted when the age-adjusted ventricular index shows the ventricles to be at the 97th percentile + 2 standard deviations. Cerebrospinal fluid is then removed from the VADs 1-3 times daily as required to maintain ventricles within these parameters.
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
de Vries LS, Liem KD, van Dijk K, Smit BJ, Sie L, Rademaker KJ, Gavilanes AW; Dutch Working Group of Neonatal Neurology. Early versus late treatment of posthaemorrhagic ventricular dilatation: results of a retrospective study from five neonatal intensive care units in The Netherlands. Acta Paediatr. 2002;91(2):212-7. doi: 10.1080/080352502317285234.
Brouwer A, Groenendaal F, van Haastert IL, Rademaker K, Hanlo P, de Vries L. Neurodevelopmental outcome of preterm infants with severe intraventricular hemorrhage and therapy for post-hemorrhagic ventricular dilatation. J Pediatr. 2008 May;152(5):648-54. doi: 10.1016/j.jpeds.2007.10.005. Epub 2007 Dec 26.
David D Limbrick, MD, PhD
Washington University School of Medicine
Amit Mathur, MD
Washington University School of Medicine
Terrie Inder, MD
Washington University School of Medicine
7 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
Ventricular access devices (VADs) are surgically implanted when cranial ultrasound measures reach treatment group-specific criteria. For the standard-threshold arm, VADs will be implanted when the age-adjusted ventricular index shows the ventricles to be at the 97th percentile. Cerebrospinal fluid is then removed from the VADs 1-3 times daily as required to maintain ventricles within these parameters.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
November 6, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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