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Trial record 2 of 2 for:    Neurological Consequences of Cytomegalovirus Infection

Postnatal Human Cytomegalovirus (HCMV) Infection in Very Preterm Infants. Implications on Acute and Chronic Morbidity, Growth and Neurodevelopmental Outcomes. Part of the Study on "Nutrition, Growth and Development Among Very Preterm Infants"

This study has been terminated.
(This study was conducted together with a nutritional study. The nutritional study was terminated, thus this study was also terminated.)
Sponsor:
Collaborators:
University of Oslo
Ullevaal University Hospital
University Hospital, Akershus
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01151462
First received: June 25, 2010
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

The aim of this study is to investigate short and long term consequences from early postnatal HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or gestational age < 32 weeks). These infants are at high risk of early death or survival with chronic disease and neurodevelopmental impairment if infected with HCMV. Infection is a common complication in this group of patients and reported to be the most frequent cause of death after the second week of life. Systemic infection in the newborn period is reported as representing an independent risk factor for survival with neurodevelopmental impairment among very preterm infants.


Condition
Neurodevelopmental Disabilities
Hearing Loss
Mental Retardation
Microcephaly
Chorioretinitis
Growth

Study Type: Observational
Official Title: Postnatal Human Cytomegalovirus (HCMV) Infection in Very Preterm Infants. Implications on Acute and Chronic Morbidity, Growth and Neurodevelopmental Outcomes Part of the Study on "Nutrition, Growth and Development Among Very Preterm Infants".

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection. [ Time Frame: > 2 weeks after birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and consequences of postnatal HCMV infection in terms of neurodevelopment disabilities including cognition, vision, hearing, movement and growth. [ Time Frame: Before 5 months of age. ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Serum. Mothersmilk. Urine.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Approximately 70 % of fertile women in Norway are seropositive for HCMV. In practically all seropositive women a reactivation of the HCMV occurs during late pregnancy and lactation. In 75 - 80 % of HCMV seropositive lactating women this reactivation can be detected as presence of infectious HCMV in breast milk and witch is pathogenic and fully capable of causing infection in both term and preterm infants. Norway is one of few countries in the world where the provision of raw unpasteurized milk from the mothers to their very premature infants is encouraged regardless of the mothers HCMV status. Within the first few days after inclusion the mothers HCMV status will be established by serological tests. Weekly samples will be collected from the mother's breast milk and the baby's urine and frozen at minus 80 degrees Celsius for later quantitative analysis for the presence of HCMV virus by PCR technique. The plan is to enrol 260 very preterm infants over a period of 2 years. Exclusion criteria are congenital malformations, chromosomal abnormalities and clinical syndromes known to affect growth, and critical illness with short life expectancy. We wish to preform Magnetic Resonance Imaging (MRI) of the brain at term and 5 months corrected age. A parent-completed Questionnaire called the Ages and Stages Questionnaire (ASQ), will be sent to the infants' parents at 6, 12 and 20 months CA. We will perform a Visual Evoked Potential (VEP) test and an eye-tracking test at 5 months CA. During the 3rd year of life we will test children's ability to insert differently formed object into fitting apertures. The aim of this study is to investigate short and long term consequences from early postnatal HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or gestational age < 32 weeks). These infants are at high risk of early death or survival with chronic disease and neuro-developmental impairment if infected with HCMV. HCMV infection is a common complication in this group of patients and reported to be the most frequent cause of death after the second week of life. This study on postnatal HCMV infection will, together with the main study on nutrition (Nutrition, growth and development among very preterm infants, NCT01103219), provide results that will create a foundation for evidence based recommendations regarding optimal nutrition of very preterm infants. Much uncertainty is attached to the consequences from providing raw human milk from HCMV seropositive mothers to their very preterm infants. Raw HCMV positive human milk given to very preterm infants may lead to unwanted consequences on health on a scale that is largely unknown and may be underrated.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Premature infants with birth weight below 1,500 grams born at Oslo University Hospital and Akershus University Hospital.

Criteria

Inclusion Criteria:

  • Birth weight below 1,500 grams
  • Written parental consent
  • Infants receiving their own mothers milk

Exclusion Criteria:

  • Congenital malformations
  • Critical illness with short life expectancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151462

Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Ullevaal University Hospital
University Hospital, Akershus
Investigators
Principal Investigator: Arild Rønnestad, Dr.med (PhD) Oslo University Hospital Rikshospitalet
  More Information

Publications:
Responsible Party: Oslo University Hospital, Arild Rønnestad, PhD
ClinicalTrials.gov Identifier: NCT01151462     History of Changes
Other Study ID Numbers: REK 2009/2249b
Study First Received: June 25, 2010
Last Updated: May 15, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Postnatal HCMV infection in very preterm infants
Neurodevelopmental disabilities
Hearing loss
Mental retardation
Microcephaly
Chorioretinitis
Growth

Additional relevant MeSH terms:
Infection
Neurologic Manifestations
Chorioretinitis
Deafness
Hearing Loss
Intellectual Disability
Microcephaly
Uveitis
Choroid Diseases
Choroiditis
Congenital Abnormalities
Craniofacial Abnormalities
Ear Diseases
Eye Diseases
Hearing Disorders
Malformations of Cortical Development
Mental Disorders
Mental Disorders Diagnosed in Childhood
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Nervous System Diseases
Nervous System Malformations
Neurobehavioral Manifestations
Otorhinolaryngologic Diseases
Panuveitis
Retinal Diseases
Retinitis
Sensation Disorders
Signs and Symptoms
Uveal Diseases

ClinicalTrials.gov processed this record on November 20, 2014