Postnatal HCMV Infection in Very Preterm Infants. Implications, Morbidity, Growth and Neurodevelopmental Outcomes.

NCT01151462 | Withdrawn DMC

• 1 other identifier: REK 2009/2249b
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss; Mental Retardation; Microcephaly; Chorioretinitis

Keywords

Postnatal HCMV infection in very preterm infants; Neurodevelopmental disabilities; Hearing loss; Mental retardation; Microcephaly; Chorioretinitis; Growth

Outcome Measures

Primary Outcomes (1)

• Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection.

  > 2 weeks after birth

Secondary Outcomes (1)

• Incidence and consequences of postnatal HCMV infection in terms of neurodevelopment disabilities including cognition, vision, hearing, movement and growth.

  Before 5 months of age.

Eligibility Criteria

• Age: 1 Week+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Congenital malformations
• Critical illness with short life expectancy

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Ullevaal University Hospital: collaborator
• University Hospital, Akershus: collaborator

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (5)

• Ronnestad A, Abrahamsen TG, Medbo S, Reigstad H, Lossius K, Kaaresen PI, Egeland T, Engelund IE, Irgens LM, Markestad T. Late-onset septicemia in a Norwegian national cohort of extremely premature infants receiving very early full human milk feeding. Pediatrics. 2005 Mar;115(3):e269-76. doi: 10.1542/peds.2004-1833. Epub 2005 Feb 1.

  PMID: 15687416 BACKGROUND

• Ronnestad A, Abrahamsen TG, Medbo S, Reigstad H, Lossius K, Kaaresen PI, Engelund IE, Irgens LM, Markestad T. Septicemia in the first week of life in a Norwegian national cohort of extremely premature infants. Pediatrics. 2005 Mar;115(3):e262-8. doi: 10.1542/peds.2004-1834. Epub 2005 Feb 1.

  PMID: 15687417 BACKGROUND

• Markestad T, Kaaresen PI, Ronnestad A, Reigstad H, Lossius K, Medbo S, Zanussi G, Engelund IE, Skjaerven R, Irgens LM; Norwegian Extreme Prematurity Study Group. Early death, morbidity, and need of treatment among extremely premature infants. Pediatrics. 2005 May;115(5):1289-98. doi: 10.1542/peds.2004-1482.

  PMID: 15867037 BACKGROUND

• Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45. doi: 10.1542/peds.2007-1511.

  PMID: 18519483 BACKGROUND

• Westerberg AC, Henriksen C, Ellingvag A, Veierod MB, Juliusson PB, Nakstad B, Aurvag AK, Ronnestad A, Gronn M, Iversen PO, Drevon CA. First year growth among very low birth weight infants. Acta Paediatr. 2010 Apr;99(4):556-62. doi: 10.1111/j.1651-2227.2009.01667.x. Epub 2010 Jan 20.

  PMID: 20096031 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum. Mothersmilk. Urine.

MeSH Terms

Conditions

Hearing Loss; Intellectual Disability; Microcephaly; Chorioretinitis

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinitis; Retinal Diseases; Eye Diseases; Choroiditis; Choroid Diseases; Uveal Diseases; Uveitis, Posterior; Panuveitis; Uveitis

Study Officials

• Arild Rønnestad, Dr.med (PhD)

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arild Rønnestad, PhD

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 23, 2022

Record last verified: 2013-05

Locations

NO (1)