Hearing Loss Clinical Trial
Official title:
Postnatal 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".
NCT number | NCT01151462 |
Other study ID # | REK 2009/2249b |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | May 2013 |
Verified date | May 2013 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Week and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Rikshospitalet | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Ullevaal University Hospital, University Hospital, Akershus, University of Oslo |
Norway,
Henriksen C, Haugholt K, Lindgren M, Aurvåg AK, Rønnestad A, Grønn 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. — View Citation
Markestad T, Kaaresen PI, Rønnestad A, Reigstad H, Lossius K, Medbø 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. — View Citation
Rønnestad A, Abrahamsen TG, Medbø 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. Epub 2005 Feb 1. — View Citation
Rønnestad A, Abrahamsen TG, Medbø 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. Epub 2005 Feb 1. — View Citation
Westerberg AC, Henriksen C, Ellingvåg A, Veierød MB, Júlíusson PB, Nakstad B, Aurvåg AK, Rønnestad A, Grønn 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection. | > 2 weeks after birth | ||
Secondary | Incidence and consequences of postnatal HCMV infection in terms of neurodevelopment disabilities including cognition, vision, hearing, movement and growth. | Before 5 months of age. |
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