Intrauterine Growth RestrictionNCT01942525
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
An observational study of Intrauterine Growth Restriction and Premature - Weight 1000g-2499g or Gestation of 28-37weeks, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was… Read more about this study
- Who is it for?
- Ages 23 to 30 weeks
- Conditions the study is for
- Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder
- What is being tested?
- aEEG
- How many people
- 156 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Sep 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 23 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Retrospectively, children with intrauterine growth restriction (defined as a birth weight below the 10th percentile) treated at the Neonatal Intensive Care Unit (NICU) of the Medical University Vienna between 2005 and 2007 were included in the study. Besides IUGR, inclusion criteria were gestational age between 23+1 and 29+6 weeks and routinely assessed aEEG measurements. Infants with congenital anomalies and severe asphyxia were excluded. The control group consists of infants of the same age with normal birth weight (>10th percentile) in the same study period.
Who may be able to join
- preterm infants below 30 weeks of gestation
Who cannot join
- congenital anomalies
- severe asphyxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.
Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.
- Conditions
- Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder, EEG; Spikes, Centrotemporal, Epilepsy of Childhood
- Being tested
- aEEG
- Keywords
- IUGR, aEEG, preterm infants, neurodevelopmental outcome
- Medical subject headings
- Fetal Growth Retardation, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aEEGOther
Also called assessment of neurodevelopmental follow-up
The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine growth restriction | birth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up Receives: Other: aEEG | |
| Appropriate for gestation age | control group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up Receives: Other: aEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories
Measured: first 14 days of life
Secondary outcomes (1)
Neurodevelopmental outcome
composite score: Bayley Scales of Infant Development (>85= normal, <70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJun 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Klebermass-Schrehof, Medical University of Vienna
- Investigators
- Katrin Klebermass-Schrehof, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942525
- Sponsor's protocol ID
- KKS-07-2013
- Status last verified
- Sep 2013
- First submitted
- 24 Aug 2013
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
- ClinicalTrials.gov ID
- NCT01942525
- Acronym / sponsor ID
- KKS-07-2013
- Conditions
- Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder, EEG; Spikes, Centrotemporal, Epilepsy of Childhood
- Keywords
- IUGR, aEEG, preterm infants, neurodevelopmental outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 16 Sep 2013 (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.
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.
Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine growth restriction | – | Other: aEEGbirth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up |
| Appropriate for gestation age | – | Other: aEEGcontrol group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up |
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Retrospectively, children with intrauterine growth restriction (defined as a birth weight below the 10th percentile) treated at the Neonatal Intensive Care Unit (NICU) of the Medical University Vienna between 2005 and 2007 were included in the study. Besides IUGR, inclusion criteria were gestational age between 23+1 and 29+6 weeks and routinely assessed aEEG measurements. Infants with congenital anomalies and severe asphyxia were excluded. The control group consists of infants of the same age with normal birth weight (>10th percentile) in the same study period.
Key inclusion criteria (1 listed)
- preterm infants below 30 weeks of gestation
Key exclusion criteria (2 listed)
- congenital anomalies
- severe asphyxia
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 |
|---|---|---|
| aEEGAlso: assessment of neurodevelopmental follow-upThe amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA) | Other | Appropriate for gestation age, Intrauterine growth restriction |
Primary outcome
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
Time frame: first 14 days of life
composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories
1 secondary outcome
Neurodevelopmental outcome
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
Katrin Klebermass-Schrehof, MD principal investigator
Medical University of Vienna
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 Intrauterine Growth Restriction and Premature - Weight 1000g-2499g or Gestation of 28-37weeks, run by Medical University of Vienna at 1 site in Austria.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2013. 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 Austria. 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?
Results are not available in the source record.
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?
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity) (time frame: first 14 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2013.