Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants

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Brief Title

Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants

Official Title

Phase II Study of Late- Versus Early Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants.

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.
    

Detailed Description

      Cranial ultrasound (CUS) is routinely performed on preterm infants ≤ 34 weeks estimated
      gestational age (EGA) on day-of-life (DOL) #3 and again on DOL #7-10. Patients with Papile
      Grade II-IV intraventricular hemorrhage (IVH) will undergo serial CUS 1-3 times weekly for 21
      days following IVH to monitor for post-hemorrhagic ventricular dilation (PHVD). Using
      standardized CUS parameters (Levene's ventricular index, Davies's diagonal anterior horn
      width and thalamo-occipital diameter), infants will be offered enrollment in the trial when
      their ventricular measures exceed the 97th percentile. Randomization to either low- or
      standard-threshold PHVD treatment will be performed by opening sequentially numbered, sealed
      envelopes. Envelopes will be prepared using a randomization schedule where allocations are
      assigned in a 1:1 ratio in blocks of 4 so that the desired 1:1 ratio will be maintained at
      periodic intervals in the study.

      Neurosurgical treatment of progressive PHVD involves surgical placement of a ventricular
      access device (VAD) for the removal of cerebrospinal fluid (CSF). Though at present clear
      criteria do not exist for CSF removal, an estimation of usual neurosurgical practice and that
      used in previous trials (standard-threshold) is intervention at Levene's EGA-adjusted 97th
      percentile for ventricular enlargement + 4 mm or greater (> 2 standard deviations > 97th
      percentile) or a diagonal width enlargement of the frontal horn > 10 mm. For the purpose of
      this study, low-threshold intervention will be defined as ventricular enlargement > 97th
      percentile with either a frontal diagonal width 7-10 mm or a thalamo-occipital diameter >24
      mm.

      CUS will be performed 2-3 times weekly in both the low- and standard-threshold groups. CSF
      will be removed under sterile conditions via VAD taps (10 ml/kg over 20 minutes, 0-4 times
      daily) as needed to maintain the CUS ventricular dimensions defined above for each treatment
      group. Treatment group-specific ventricular size must be achieved within 48-72 hours of VAD
      placement, and ventricles must be maintained within this range throughout the duration of
      treatment.

      If CSF removal is still required at 44 weeks EGA and there is consensus among the treating
      neonatologist and neurosurgeon, permanent VP shunts will be surgically implanted. The rate of
      VP shunts required by 44 weeks EGA and by 12 months corrected age will be monitored. Formal
      neurodevelopmental evaluations will be performed by a blinded developmental psychologist at
      18-24 months corrected age to assess neurocognitive and psychomotor function in low- versus
      standard-threshold groups. Each infant will be scored using the Bayley Scales of Infant
      Development.
    


Study Type

Interventional


Primary Outcome

Ventriculoperitoneal shunt-dependence

Secondary Outcome

 Shunt malfunction

Condition

Intraventricular Hemorrhage

Intervention

Removal of CSF through ventricular access device

Study Arms / Comparison Groups

 Standard threshold
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

7

Start Date

May 2009

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Infants with congenital cerebral malformations

          -  Cystic periventricular leukomalacia

          -  CNS infection, metabolic disease

          -  PHVD present at birth will be excluded from the study.
      

Gender

All

Ages

N/A - 34 Weeks

Accepts Healthy Volunteers

No

Contacts

David D Limbrick, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00875758

Organization ID

LETAP-09-0380


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine


Study Sponsor

David D Limbrick, MD, PhD, Principal Investigator, Washington University School of Medicine


Verification Date

November 2017