Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
torstai 13. elokuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
109
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Birmingham, Yhdistynyt kuningaskunta, B9 5SS
- Birmingham Heartlands Hospital
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Liverpool, Yhdistynyt kuningaskunta, L12 2AP
- Alder Hey Childrens Hospital
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Newcastle Upon Tyne, Yhdistynyt kuningaskunta, NE4 6BE
- Newcastle General Hospital
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Bristol, City of
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Bristol, Bristol, City of, Yhdistynyt kuningaskunta, BS2 8AE
- Bristol Royal Hospital for Children - UBHT Education Centre
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London, City of
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London, London, City of, Yhdistynyt kuningaskunta, NW3 2PF
- University College London - Royal Free Campus - Virology
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London, London, City of, Yhdistynyt kuningaskunta, SW17 0QT
- Saint George's Hospital - Pediatric Infectious Diseases
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Oxfordshire
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Oxford, Oxfordshire, Yhdistynyt kuningaskunta, OX3 9DU
- John Radcliffe Hospital
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35233-1711
- University of Alabama - Children's of Alabama - Clinical Virology
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Mobile, Alabama, Yhdysvallat, 36604-3207
- University of South Alabama - Children's Specialty Clinic
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Arkansas
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Little Rock, Arkansas, Yhdysvallat, 72202-3500
- Arkansas Children's Hospital - Infectious Diseases
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California
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Los Angeles, California, Yhdysvallat, 90033-1075
- Los Angeles County - University of Southern California - Medical Center - Pediatrics
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Los Angeles, California, Yhdysvallat, 90048-5970
- Plaza Towers Obstetrics and Gynecology
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Orange, California, Yhdysvallat, 92868-3835
- Children's Hospital of Orange County - Infectious Diseases
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Stanford, California, Yhdysvallat, 94305-2200
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, Yhdysvallat, 80045-7106
- Children's Hospital Colorado - Infectious Disease
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District of Columbia
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Washington, District of Columbia, Yhdysvallat, 20010-2916
- Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
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Florida
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Jacksonville, Florida, Yhdysvallat, 32209-6511
- University of Florida - College of Medicine - Jacksonville
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Tampa, Florida, Yhdysvallat, 33606-3438
- University of South Florida - Tampa General Hospital - Pediatrics
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30322-1014
- Emory Children's Center - Pediatric Infectious Diseases
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40202-1821
- University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70112-2600
- Tulane University - Tulane Medical Center - Pediatrics
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Shreveport, Louisiana, Yhdysvallat, 71103-4228
- Louisiana State University Health Shreveport - Pediatrics
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21287-0011
- Johns Hopkins Children's Center - Pediatric Infectious Diseases
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02115-5711
- Children's Hospital Boston - Infectious Diseases
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Minnesota
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Minneapolis, Minnesota, Yhdysvallat, 55455-0341
- University of Minnesota - Pediatric Infectious Disease
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Mississippi
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Jackson, Mississippi, Yhdysvallat, 39216-4505
- University of Mississippi - Children's Infectious Diseases
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Missouri
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Kansas City, Missouri, Yhdysvallat, 64108-4619
- Children's Mercy Hospital and Clinics - Infectious Diseases
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Saint Louis, Missouri, Yhdysvallat, 63110-1010
- Washington University School of Medicine in St. Louis - Center for Clinical Studies
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68131-2137
- Creighton University Medical Center - Medicine - Infectious Diseases
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New Jersey
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New Brunswick, New Jersey, Yhdysvallat, 08901-1766
- Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases
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New Brunswick, New Jersey, Yhdysvallat, 08901-1935
- Robert Wood Johnson Medical School - Pediatrics
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New York
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Buffalo, New York, Yhdysvallat, 14222-2006
- Women & Children's Hospital of Buffalo - Infectious Diseases
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Manhasset, New York, Yhdysvallat, 11030-3816
- Cohen Children's Medical Center - Pediatric Infectious Diseases
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Rochester, New York, Yhdysvallat, 14642-0001
- University of Rochester Medical Center - Golisano Children's Hospital - Infectious Diseases
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Syracuse, New York, Yhdysvallat, 13210-2342
- SUNY Upstate Medical University Hospital - Pediatrics
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28203-5812
- Carolinas Medical Center - Pediatrics - Infectious Diseases
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44109-1998
- MetroHealth Medical Center - Pediatric Infectious Disease
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Cleveland, Ohio, Yhdysvallat, 44195-0001
- Cleveland Clinic Main Campus - Center for Pediatric Infectious Diseases
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Columbus, Ohio, Yhdysvallat, 43205-2664
- Nationwide Children's Hospital - Infectious Diseases
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15224-1529
- Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02903-4923
- Rhode Island Hospital - Pediatrics
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29425-8903
- Medical University of South Carolina - Pediatrics - Infectious Diseases
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Tennessee
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Nashville, Tennessee, Yhdysvallat, 37232-0011
- Vanderbilt University - Pediatric - Infectious Diseases
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Texas
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Dallas, Texas, Yhdysvallat, 75235-7701
- Children's Medical Center Dallas - Neonatal ICU
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Dallas, Texas, Yhdysvallat, 75390-9063
- University of Texas Southwestern Medical Center - Pediatrics
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Fort Worth, Texas, Yhdysvallat, 76104-2710
- Cook Children's Infectious Disease Services
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84108-1457
- University of Utah - Pediatric Pharmacology Program
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Washington
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Seattle, Washington, Yhdysvallat, 98105-3901
- Seattle Children's Hospital - Infectious Diseases
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
Ei vanhempi kuin 4 viikkoa (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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:
- Thrombocytopenia
- Petechiae
- Hepatomegaly
- Splenomegaly
- Intrauterine growth restriction
- Hepatitis (elevated transaminases and/or bilirubin)
- 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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Valganciclovir
Six months of oral Valganciclovir.
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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.
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Placebo Comparator: Placebo
Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Best Ear Hearing Assessments at 6 Months.
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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).
Aikaikkuna: 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.
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12 Months after enrollment
|
|
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Aikaikkuna: 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).
Aikaikkuna: 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
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Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Aikaikkuna: 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.
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12 Months after enrollment
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Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Aikaikkuna: 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.
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12 Months after enrollment
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Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Aikaikkuna: 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.
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12 Months after enrollment
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Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Aikaikkuna: 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).
Aikaikkuna: 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).
Aikaikkuna: 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
|
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Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Aikaikkuna: 24 Months after enrollment
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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.
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24 Months after enrollment
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Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Aikaikkuna: 24 Months after enrollment
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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.
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24 Months after enrollment
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Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Aikaikkuna: 24 Months after enrollment
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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.
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24 Months after enrollment
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Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Aikaikkuna: 24 Months after enrollment.
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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.
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24 Months after enrollment.
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Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Aikaikkuna: 24 Months after enrollment
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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.
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24 Months after enrollment
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. kesäkuuta 2008
Ensisijainen valmistuminen (Todellinen)
Torstai 1. joulukuuta 2011
Opintojen valmistuminen (Todellinen)
Lauantai 1. kesäkuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 26. huhtikuuta 2007
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 26. huhtikuuta 2007
Ensimmäinen Lähetetty (Arvio)
Perjantai 27. huhtikuuta 2007
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 26. elokuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 13. elokuuta 2015
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 06-0046
- CASG 112
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .