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

September 21, 2022 updated by: Kenneth Strømmen, Oslo University Hospital

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".

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection.
Time Frame: > 2 weeks after birth
> 2 weeks after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Before 5 months of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
Ullevaal University Hospital
University Hospital, Akershus

Investigators

  • Principal Investigator: Arild Rønnestad, Dr.med (PhD), Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 2009/2249b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Microcephaly

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe