Neonatal HyperbilirubinemiaNCT01599611
Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
An observational study of Neonatal Hyperbilirubinemia, run by University of Aarhus.
Trial summary
The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Movement assessment battery for children - 2
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jan 2011
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: All children born in Denmark in the period 01.01.2000 - 31.12.2005 with a gestational age >= 35 weeks and a total serum bilirubin > 450 umol/L and a matched control group of children
Who may be able to join
- Gestational age > 35 weeks
- Total serum bilirubin > 450 umol/L in the neonatal period
- Born in the period 01.01.2000 - 31.12.2005
Who cannot join
- Acute intermediate or advanced bilirubin encephalopathy
About this study
The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.
Read the detailed description
Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Movement assessment battery for children - 2
- Keywords
- Neonatal hyperbilirubinemia, Follow-up, Motor development, Hearing, Executive function
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement assessment battery for children - 2Procedure or surgery
Also called MABC-2
A standardised test developed to identify developmental difficulties in children.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period Receives: Procedure: Movement assessment battery for children - 2 | |
| Non-exposed group | Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence Receives: Procedure: Movement assessment battery for children - 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development
Delayed motor development for children in the exposed group compared to children in the non-exposed group
Measured: Age 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pernille Vandborg, MD, PhD, Principal investigator, Børneafdelingen, Aalborg Sygehus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599611
- Sponsor's protocol ID
- pkv
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Vandborg PK, Hansen BM, Greisen G, Mathiasen R, Kasper F, Ebbesen F. Follow-up of extreme neonatal hyperbilirubinaemia in 5- to 10-year-old children: a Danish population-based study. Dev Med Child Neurol. 2015 Apr;57(4):378-84. doi: 10.1111/dmcn.12603. Epub 2014 Oct 29.
PubMed 25353277
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
- ClinicalTrials.gov ID
- NCT01599611
- Acronym / sponsor ID
- pkv
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Neonatal hyperbilirubinemia, Follow-up, Motor development, Hearing, Executive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 May 2012 (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 objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.
Detailed description
Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Procedure: Movement assessment battery for children - 2Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period |
| Non-exposed group | – | Procedure: Movement assessment battery for children - 2Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children born in Denmark in the period 01.01.2000 - 31.12.2005 with a gestational age >= 35 weeks and a total serum bilirubin > 450 umol/L and a matched control group of children
Key inclusion criteria (3 listed)
- Gestational age > 35 weeks
- Total serum bilirubin > 450 umol/L in the neonatal period
- Born in the period 01.01.2000 - 31.12.2005
Key exclusion criteria (1 listed)
- Acute intermediate or advanced bilirubin encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement assessment battery for children - 2Also: MABC-2A standardised test developed to identify developmental difficulties in children. | Procedure or surgery | Exposed group, Non-exposed group |
Primary outcome
Motor development
Time frame: Age 5-10 years
Delayed motor development for children in the exposed group compared to children in the non-exposed group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Derived from this study: PubMed 25353277Vandborg PK, Hansen BM, Greisen G, Mathiasen R, Kasper F, Ebbesen F. Follow-up of extreme neonatal hyperbilirubinaemia in 5- to 10-year-old children: a Danish population-based study. Dev Med Child Neurol. 2015 Apr;57(4):378-84. doi: 10.1111/dmcn.12603. Epub 2014 Oct 29.
- A description of the study in DanishLink provided by the sponsor.
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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.
Pernille Vandborg, MD, PhD principal investigator
Børneafdelingen, Aalborg Sygehus, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia, run by University of Aarhus.
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 1 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: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor development (time frame: Age 5-10 years). 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 NCT01599611, which also lists 1 linked publication.
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 16 May 2012.