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

Withdrawn

• Conditions: Hearing Loss; Microcephaly; Mental Retardation; Chorioretinitis

• Registration Number: NCT01151462
• Lead Sponsor: Oslo University Hospital

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.

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.

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Study Start: 2010-08
• Primary Completion: 2013-01
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence and consequences of postnatal HCMV infection in terms of neurodevelopment disabilities including cognition, vision, hearing, movement and growth.	Before 5 months of age.

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway