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Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

13 sierpnia 2015 zaktualizowane przez: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase III, Randomized, Placebo-Controlled Blinded Investigation of Six Weeks vs. Six Months of Oral Valganciclovir Therapy in Infants With Symptomatic Congenital Cytomegalovirus Infection (CASG 112)

Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment. Patients will be followed for the study related evaluations of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study is a multi-center, prospective, international, Phase III, randomized and blinded investigation of 6 weeks versus 6 months of oral valganciclovir therapy in babies with symptomatic congenital cytomegalovirus (CMV) disease. Following enrollment, study subjects will receive 6 weeks of oral valganciclovir. Near the end of the 6-week course, subjects will be randomized in a 1:1 fashion either to continue on valganciclovir to complete 6 months of therapy or to begin a matching placebo to complete the 6 months. Study subjects will be stratified according to whether or not there is central nervous system (CNS) involvement at study entry. During the 6-month treatment period and the 1 month thereafter, study subjects will be followed weekly for 4 weeks, then every other week for 8 weeks, then every month for 4 months. At each of these visits, safety labs will be checked, growth parameters recorded, and adverse events assessed. The dose of study medication will be adjusted for weight gain at each of these study visits. Dose adjustments may also occur as indicated per protocol for neutropenia, thrombocytopenia, or renal impairment. Whole blood will be obtained for CMV viral load at each of these visits as well. Hearing outcomes will be assessed at baseline, 6 months, 12 months and 24 months. Developmental outcomes will be assessed at 12 months and 24 months. Changes in whole blood viral load measurements will be correlated with both hearing and neurologic outcomes. In study subjects with increasing whole blood viral loads during the course of treatment, assessment for antiviral resistance may be undertaken.Safety assessments include: hematology labs, chemistry labs, physical examinations, and adverse event data performed/collected serially. Development of neutropenia will be confirmed by repeat blood testing within one week, and study drug will be held until it resolves. Efficacy assessments include: hearing assessments at baseline, 6 months, 12 months and 24 months; and neurodevelopmental assessments at 12 months and 24 months. Study objectives are: to compare the impact on hearing outcomes of 6 weeks versus 6 months of antiviral treatment with valganciclovir oral solution in infants with symptomatic congenital CMV disease; to compare the safety profile of 6 weeks versus 6 months of antiviral therapy with valganciclovir oral solution in infants with symptomatic congenital CMV disease; to compare the impact on neurologic outcomes of 6 weeks versus 6 months of antiviral treatment with valganciclovir oral solution in infants with symptomatic congenital CMV disease; and to correlate change in whole blood viral load with hearing and neurologic outcomes. Participants will include 104 male and female neonates (less than or equal to 30 days) with symptomatic congenital CMV.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

109

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233-1711
        • University of Alabama - Children's of Alabama - Clinical Virology
      • Mobile, Alabama, Stany Zjednoczone, 36604-3207
        • University of South Alabama - Children's Specialty Clinic
    • Arkansas
      • Little Rock, Arkansas, Stany Zjednoczone, 72202-3500
        • Arkansas Children's Hospital - Infectious Diseases
    • California
      • Los Angeles, California, Stany Zjednoczone, 90033-1075
        • Los Angeles County - University of Southern California - Medical Center - Pediatrics
      • Los Angeles, California, Stany Zjednoczone, 90048-5970
        • Plaza Towers Obstetrics and Gynecology
      • Orange, California, Stany Zjednoczone, 92868-3835
        • Children's Hospital of Orange County - Infectious Diseases
      • Stanford, California, Stany Zjednoczone, 94305-2200
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045-7106
        • Children's Hospital Colorado - Infectious Disease
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20010-2916
        • Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
    • Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32209-6511
        • University of Florida - College of Medicine - Jacksonville
      • Tampa, Florida, Stany Zjednoczone, 33606-3438
        • University of South Florida - Tampa General Hospital - Pediatrics
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322-1014
        • Emory Children's Center - Pediatric Infectious Diseases
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202-1821
        • University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone, 70112-2600
        • Tulane University - Tulane Medical Center - Pediatrics
      • Shreveport, Louisiana, Stany Zjednoczone, 71103-4228
        • Louisiana State University Health Shreveport - Pediatrics
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287-0011
        • Johns Hopkins Children's Center - Pediatric Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02115-5711
        • Children's Hospital Boston - Infectious Diseases
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455-0341
        • University of Minnesota - Pediatric Infectious Disease
    • Mississippi
      • Jackson, Mississippi, Stany Zjednoczone, 39216-4505
        • University of Mississippi - Children's Infectious Diseases
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64108-4619
        • Children's Mercy Hospital and Clinics - Infectious Diseases
      • Saint Louis, Missouri, Stany Zjednoczone, 63110-1010
        • Washington University School of Medicine in St. Louis - Center for Clinical Studies
    • Nebraska
      • Omaha, Nebraska, Stany Zjednoczone, 68131-2137
        • Creighton University Medical Center - Medicine - Infectious Diseases
    • New Jersey
      • New Brunswick, New Jersey, Stany Zjednoczone, 08901-1766
        • Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases
      • New Brunswick, New Jersey, Stany Zjednoczone, 08901-1935
        • Robert Wood Johnson Medical School - Pediatrics
    • New York
      • Buffalo, New York, Stany Zjednoczone, 14222-2006
        • Women & Children's Hospital of Buffalo - Infectious Diseases
      • Manhasset, New York, Stany Zjednoczone, 11030-3816
        • Cohen Children's Medical Center - Pediatric Infectious Diseases
      • Rochester, New York, Stany Zjednoczone, 14642-0001
        • University of Rochester Medical Center - Golisano Children's Hospital - Infectious Diseases
      • Syracuse, New York, Stany Zjednoczone, 13210-2342
        • SUNY Upstate Medical University Hospital - Pediatrics
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone, 28203-5812
        • Carolinas Medical Center - Pediatrics - Infectious Diseases
    • Ohio
      • Cleveland, Ohio, Stany Zjednoczone, 44109-1998
        • MetroHealth Medical Center - Pediatric Infectious Disease
      • Cleveland, Ohio, Stany Zjednoczone, 44195-0001
        • Cleveland Clinic Main Campus - Center for Pediatric Infectious Diseases
      • Columbus, Ohio, Stany Zjednoczone, 43205-2664
        • Nationwide Children's Hospital - Infectious Diseases
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224-1529
        • Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02903-4923
        • Rhode Island Hospital - Pediatrics
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425-8903
        • Medical University of South Carolina - Pediatrics - Infectious Diseases
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37232-0011
        • Vanderbilt University - Pediatric - Infectious Diseases
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75235-7701
        • Children's Medical Center Dallas - Neonatal ICU
      • Dallas, Texas, Stany Zjednoczone, 75390-9063
        • University of Texas Southwestern Medical Center - Pediatrics
      • Fort Worth, Texas, Stany Zjednoczone, 76104-2710
        • Cook Children's Infectious Disease Services
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84108-1457
        • University of Utah - Pediatric Pharmacology Program
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98105-3901
        • Seattle Children's Hospital - Infectious Diseases
  • Zjednoczone Królestwo
      • Birmingham, Zjednoczone Królestwo, B9 5SS
        • Birmingham Heartlands Hospital
      • Liverpool, Zjednoczone Królestwo, L12 2AP
        • Alder Hey Childrens Hospital
      • Newcastle Upon Tyne, Zjednoczone Królestwo, NE4 6BE
        • Newcastle General Hospital
    • Bristol, City of
      • Bristol, Bristol, City of, Zjednoczone Królestwo, BS2 8AE
        • Bristol Royal Hospital for Children - UBHT Education Centre
    • London, City of
      • London, London, City of, Zjednoczone Królestwo, NW3 2PF
        • University College London - Royal Free Campus - Virology
      • London, London, City of, Zjednoczone Królestwo, SW17 0QT
        • Saint George's Hospital - Pediatric Infectious Diseases
    • Oxfordshire
      • Oxford, Oxfordshire, Zjednoczone Królestwo, OX3 9DU
        • John Radcliffe Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Nie starszy niż 1 miesiąc (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Signed informed consent from parent(s) or legal guardian(s)
  • Confirmation of cytomegalovirus (CMV) from urine or throat swab specimens by culture, shell vial, or polymerase chain reaction (PCR) tests

  • Symptomatic congenital CMV disease, as manifest by one or more of the following:

    1. Thrombocytopenia
    2. Petechiae
    3. Hepatomegaly
    4. Splenomegaly
    5. Intrauterine growth restriction
    6. Hepatitis (elevated transaminases and/or bilirubin)
    7. Central nervous system (CNS) involvement of the CMV disease [such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal cerebrospinal fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response {ABR}), and/or positive CMV PCR from CSF]
  • Less than or equal to 30 days of age at study enrollment
  • Weight at study enrollment greater than or equal to 1800 grams
  • Gestational age greater than or equal to 32 weeks at birth

Exclusion Criteria:

  • Imminent demise
  • Patients receiving other antiviral agents or immune globulin
  • Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
  • Documented renal insufficiency, as noted by a creatinine clearance less than 10 mL/min/1.73m^2 at time of study enrollment
  • Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribivir
  • Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry)
  • Current receipt of other investigational drugs

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Valganciclovir
Six months of oral Valganciclovir.
Lek: Valganciclovir
Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Komparator placebo: Placebo
Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Inny: Placebo
9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Best Ear Hearing Assessments at 6 Months.
Ramy czasowe: Between baseline and 6 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.
Ramy czasowe: baseline through 7 months
Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.
baseline through 7 months
Change in Best Ear Hearing Assessments at 12 Months.
Ramy czasowe: Between baseline and 12 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 12 months
Change in Best Ear Hearing Assessments at 24 Months.
Ramy czasowe: Between baseline and 24 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 24 months
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 6 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 6 months
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 12 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 12 months
Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 24 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 24 months
Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 6 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 6 months
Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 12 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 12 months
Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Ramy czasowe: Between baseline and 24 months
Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.
Between baseline and 24 months
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Ramy czasowe: 12 Months after enrollment
Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
12 Months after enrollment
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Ramy czasowe: 12 Months after enrollment
Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
12 Months after enrollment
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Ramy czasowe: 12 Months after enrollment
Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
12 Months after enrollment
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Ramy czasowe: 12 Months after enrollment
Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
12 Months after enrollment
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Ramy czasowe: 12 Months after enrollment
Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
12 Months after enrollment
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Ramy czasowe: 12 Months after enrollment
Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
12 Months after enrollment
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Ramy czasowe: 12 Months after enrollment
Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
12 Months after enrollment
Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Ramy czasowe: 24 Months after enrollment
Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
24 Months after enrollment
Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Ramy czasowe: 24 months after enrollment
Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
24 months after enrollment
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Ramy czasowe: 24 Months after enrollment
Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
24 Months after enrollment
Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Ramy czasowe: 24 Months after enrollment
Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
24 Months after enrollment
Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Ramy czasowe: 24 Months after enrollment
Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
24 Months after enrollment
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Ramy czasowe: 24 Months after enrollment.
Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
24 Months after enrollment.
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Ramy czasowe: 24 Months after enrollment
Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
24 Months after enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2008

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2011

Ukończenie studiów (Rzeczywisty)

1 czerwca 2013

Daty rejestracji na studia

Pierwszy przesłany

26 kwietnia 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 kwietnia 2007

Pierwszy wysłany (Oszacować)

27 kwietnia 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

26 sierpnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 sierpnia 2015

Ostatnia weryfikacja

1 lipca 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 06-0046
  • CASG 112

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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