Premature BirthNCT00676247
Cerebral Blood Flow Parameters and Neurobehavioral Development in Infants at Term Age
An observational study of Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although several studies have contrasted the hemodynamics of cerebral arteries using cranial Doppler ultrasound between full-term and preterm infants, the assessments were mostly conducted in the first days of life. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to May 2008
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns in the primary care clinic
Who may be able to join
- birth weight higher than 2,500 g
- appropriate for gestational age
- gestation age within 38 and 42 weeks
- birth weight less than 1,500 g
- gestational age less than 37 weeks
- admission at the hospitals within 7 days after birth
Who cannot join
- chromosomal or congenital abnormalities
- Preterm group
- chromosomal or congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Blood Flow Parameters and Neurobehavioral Development in Full-Term Infants and Very Low Birth Weight Preterm Infants at Term Age
Although several studies have contrasted the hemodynamics of cerebral arteries using cranial Doppler ultrasound between full-term and preterm infants, the assessments were mostly conducted in the first days of life. Furthermore, the clinically significant hemodynamic parameter has been established from a small sample of infants that its validity on other populations remains unclear. Therefore, the purpose of this study is twofold:
- to examine the hemodynamics of cerebral arteries in full-term and very low birth weight preterm infants at term age
- to assess the validity of the hemodynamic parameters in relation to concurrent neurobehavioral function.
This study will enroll normal full-term infants and very low birth weight preterm infants who have no major neonatal disease. Cranial Doppler ultrasound examination will be performed on all infants at term age. Hemodynamic parameters will include peak systolic velocity, end diastolic velocity, resistance index and pulsatility index for the bilateral anterior cerebral arteries and middle cerebral arteries. Neurobehavioral development will be administered on the same day using the Neonatal Neurobehavioral Examination- Chinese version.
Read the detailed description
We estimate the sample size of this study based on the cerebral blood flow velocity data of Kempley's study that showed 7.2 ± 3.5 and 10.7 ± 2.4 cm/s for the MCAs in 13 preterm and 8 full-term infants, respectively. As the power is set at 0.8 and the α level is at 0.05, at least 17 subjects were required for each group. This study will include 20 full-term and 20 VLBW preterm infants who are born at the National Taiwan University Hospital (NTUH) and the Mackay Memorial Hospital (MMH), Taipei, Taiwan. Written informed consent will be obtained from the parents before participation in this study.
Cranial Doppler ultrasound and the NNE-C examinations will be performed within 5 days after birth on full-term infants and at post-menstrual age (PMA) of 40 weeks (± 1 week) on preterm infants in the baby room. If the examination time occurs after hospital discharge, assessment will be conducted in the baby room at NTUH or in the ultrasound examination room at MMH. The examinations will be performed when the babies show stable vital signs in daily activities. The NNE-C examination will be administered one hour prior to feeding to minimize distress. The NNE-C examination will be performed immediately after the ultrasound assessment. The two examinations will be performed by different examiners who were blind to each other's results. During brain Doppler ultrasound examination, each infant will be placed on the back in a baby crib or an incubator with his/her head in midline. Infant's behavioral state will be kept in the behavioral state of 1 (quiet sleep), 2 (active sleep), or 3 (drowsy) on Brazelton's classification to eliminate the impact on cerebral blood flow velocity.
Hemodynamic parameters will include PSV, EDV, RI, and PI from bilateral ACAs and MCAs as obtained by the pulse wave color Doppler. The ACA will be approached through the anterior fontanel on the sagittal plane and its blood flow velocity will be determined at the proximal part. The MCA will be approached under the transverse plane by placing the transducer on the temporal bone below the zygomatic arch. The flow velocity measurements will be obtained by Fourier transform analysis from homogeneous blood flow wave patterns over at least 3 cardiac cycles with good clear signals. Those signals that show complete and similar waveforms in the adjacent cycles and have high magnitudes with visible margin recognized from the background noise will be selected. The RI and PI are the ratio between the different velocities with the formulas: RI = (PSV-EDV) / PSV, PI = (PSV-EDV) / mean velocity. The whole ultrasound examination will take about 10 minutes.
- Conditions
- Premature Birth
- Keywords
- Ultrasonography, Doppler, Hemodynamics, Neurobehavioral development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preterm | Very-low-birth-weight preterm infants with brain lesion | |
| full-term | Healthy fullterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow velocity
Measured: post-conceptional age=40 weeks
Secondary outcomes (1)
Neonatal Neurobehavioral Examination
Measured: post-conceptional age=40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Suh-Fang Jeng, Doctor, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676247
- Sponsor's protocol ID
- 200802011R
- Status last verified
- Jan 2009
- First submitted
- 7 May 2008
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow Parameters and Neurobehavioral Development in Full-Term Infants and Very Low Birth Weight Preterm Infants at Term Age
- ClinicalTrials.gov ID
- NCT00676247
- Acronym / sponsor ID
- 200802011R
- Conditions
- Premature Birth
- Keywords
- Ultrasonography, Doppler, Hemodynamics, Neurobehavioral development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 May 2008 (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.
Although several studies have contrasted the hemodynamics of cerebral arteries using cranial Doppler ultrasound between full-term and preterm infants, the assessments were mostly conducted in the first days of life. Furthermore, the clinically significant hemodynamic parameter has been established from a small sample of infants that its validity on other populations remains unclear. Therefore, the purpose of this study is twofold:
- to examine the hemodynamics of cerebral arteries in full-term and very low birth weight preterm infants at term age
- to assess the validity of the hemodynamic parameters in relation to concurrent neurobehavioral function.
This study will enroll normal full-term infants and very low birth weight preterm infants who have no major neonatal disease. Cranial Doppler ultrasound examination will be performed on all infants at term age. Hemodynamic parameters will include peak systolic velocity, end diastolic velocity, resistance index and pulsatility index for the bilateral anterior cerebral arteries and middle cerebral arteries. Neurobehavioral development will be administered on the same day using the Neonatal Neurobehavioral Examination- Chinese version.
Detailed description
We estimate the sample size of this study based on the cerebral blood flow velocity data of Kempley's study that showed 7.2 ± 3.5 and 10.7 ± 2.4 cm/s for the MCAs in 13 preterm and 8 full-term infants, respectively. As the power is set at 0.8 and the α level is at 0.05, at least 17 subjects were required for each group. This study will include 20 full-term and 20 VLBW preterm infants who are born at the National Taiwan University Hospital (NTUH) and the Mackay Memorial Hospital (MMH), Taipei, Taiwan. Written informed consent will be obtained from the parents before participation in this study.
Cranial Doppler ultrasound and the NNE-C examinations will be performed within 5 days after birth on full-term infants and at post-menstrual age (PMA) of 40 weeks (± 1 week) on preterm infants in the baby room. If the examination time occurs after hospital discharge, assessment will be conducted in the baby room at NTUH or in the ultrasound examination room at MMH. The examinations will be performed when the babies show stable vital signs in daily activities. The NNE-C examination will be administered one hour prior to feeding to minimize distress. The NNE-C examination will be performed immediately after the ultrasound assessment. The two examinations will be performed by different examiners who were blind to each other's results. During brain Doppler ultrasound examination, each infant will be placed on the back in a baby crib or an incubator with his/her head in midline. Infant's behavioral state will be kept in the behavioral state of 1 (quiet sleep), 2 (active sleep), or 3 (drowsy) on Brazelton's classification to eliminate the impact on cerebral blood flow velocity.
Hemodynamic parameters will include PSV, EDV, RI, and PI from bilateral ACAs and MCAs as obtained by the pulse wave color Doppler. The ACA will be approached through the anterior fontanel on the sagittal plane and its blood flow velocity will be determined at the proximal part. The MCA will be approached under the transverse plane by placing the transducer on the temporal bone below the zygomatic arch. The flow velocity measurements will be obtained by Fourier transform analysis from homogeneous blood flow wave patterns over at least 3 cardiac cycles with good clear signals. Those signals that show complete and similar waveforms in the adjacent cycles and have high magnitudes with visible margin recognized from the background noise will be selected. The RI and PI are the ratio between the different velocities with the formulas: RI = (PSV-EDV) / PSV, PI = (PSV-EDV) / mean velocity. The whole ultrasound examination will take about 10 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm | – | –Very-low-birth-weight preterm infants with brain lesion |
| full-term | – | –Healthy fullterm infants |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns in the primary care clinic
Key inclusion criteria (6 listed)
- birth weight higher than 2,500 g
- appropriate for gestational age
- gestation age within 38 and 42 weeks
- birth weight less than 1,500 g
- gestational age less than 37 weeks
Key exclusion criteria (3 listed)
- chromosomal or congenital abnormalities
- Preterm group
- chromosomal or congenital abnormalities
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
Cerebral blood flow velocity
Time frame: post-conceptional age=40 weeks
1 secondary outcome
Neonatal Neurobehavioral Examination
Time frame: post-conceptional age=40 weeks
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 21 Jan 2009.
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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.
Suh-Fang Jeng, Doctor study chair
National Taiwan University
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 Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 3 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 21 Jan 2009. 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 Taiwan. 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 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?
Cerebral blood flow velocity (time frame: post-conceptional age=40 weeks). 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 21 Jan 2009.