Hearing LossNCT01151462
Postnatal HCMV Infection in Very Preterm Infants. Implications, Morbidity, Growth and Neurodevelopmental Outcomes.
An observational study of Hearing Loss and Mental Retardation, run by Oslo University Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 week and older
- Conditions the study is for
- Hearing Loss, Mental Retardation, Microcephaly
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature infants with birth weight below 1,500 grams born at Oslo University Hospital and Akershus University Hospital.
Who may be able to join
- Birth weight below 1,500 grams
- Written parental consent
- Infants receiving their own mothers milk
Who cannot join
- Congenital malformations
- Critical illness with short life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
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".
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.
Read the 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.
- Conditions
- Hearing Loss, Mental Retardation, Microcephaly, Chorioretinitis
- Keywords
- Postnatal HCMV infection in very preterm infants, Neurodevelopmental disabilities, Hearing loss, Mental retardation, Microcephaly, Chorioretinitis, Growth
- Medical subject headings
- Hearing Loss, Intellectual Disability, Microcephaly, Chorioretinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection.
Measured: > 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.
Measured: Before 5 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionMay 2013
Why it stopped: The study was terminated prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Ullevaal University Hospital, University Hospital, Akershus
- Responsible party
- Principal investigator, Kenneth Strømmen, Oslo University Hospital
- Investigators
- Arild Rønnestad, Dr.med (PhD), Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151462
- Sponsor's protocol ID
- REK 2009/2249b
- Status last verified
- May 2013
- First submitted
- 25 Jun 2010
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15687416Ronnestad 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.
PubMed 15687417Markestad 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.
PubMed 15867037Henriksen 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.
PubMed 18519483Westerberg 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.
PubMed 20096031
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT01151462
- Acronym / sponsor ID
- REK 2009/2249b
- Conditions
- Hearing Loss, Mental Retardation, Microcephaly, Chorioretinitis
- Keywords
- Postnatal HCMV infection in very preterm infants, Neurodevelopmental disabilities, Hearing loss, Mental retardation, Microcephaly, Chorioretinitis, Growth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was terminated prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Ullevaal University Hospital, University Hospital, Akershus
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 1 week and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature infants with birth weight below 1,500 grams born at Oslo University Hospital and Akershus University Hospital.
Key inclusion criteria (3 listed)
- Birth weight below 1,500 grams
- Written parental consent
- Infants receiving their own mothers milk
Key exclusion criteria (2 listed)
- Congenital malformations
- Critical illness with short life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection.
Time frame: > 2 weeks after birth
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 15687416Ronnestad 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.
- Background: PubMed 15687417Ronnestad 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.
- Background: PubMed 15867037Markestad 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.
- Background: PubMed 18519483Henriksen 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.
- Background: PubMed 20096031Westerberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arild Rønnestad, Dr.med (PhD) principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Mental Retardation, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive HCMV PCR in urine > 2 weeks after birth is diagnostic for postnatal HCMV infection. (time frame: > 2 weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151462, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.