Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants

NCT00875758 | Completed DMC

• 1 other identifier: LETAP-09-0380
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraventricular Hemorrhage; Hydrocephalus

Keywords

preterm infants; IVH; germinal matrix; intraventricular hemorrhage; hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Ventriculoperitoneal shunt-dependence

  One year

Secondary Outcomes (4)

• Shunt malfunction

  4 years

• Unnecessary device implantation

  One year

• Shunt infection

  One year

• Neurodevelopmental Outcome

  18-24 months of age

Study Arms (2)

Standard threshold

ACTIVE COMPARATOR

Procedure: Removal of CSF through ventricular access device

Low-threshold

EXPERIMENTAL

Procedure: Removal of CSF through a ventricular access device

Interventions

Removal of CSF through ventricular access device PROCEDURE

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.

Standard threshold

Removal of CSF through a ventricular access device PROCEDURE

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.

Low-threshold

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 11952011 BACKGROUND

• 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.

  PMID: 18410767 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• David D Limbrick, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Amit Mathur, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Terrie Inder, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)