Cerebral Blood Flow Parameters and Neurobehavioral Development in Infants at Term Age

January 19, 2009 updated by: National Taiwan University Hospital

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:

  1. to examine the hemodynamics of cerebral arteries in full-term and very low birth weight preterm infants at term age
  2. 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1

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

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

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

No older than 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns in the primary care clinic

Description

Fullterm group

Inclusion Criteria:

  • birth weight higher than 2,500 g
  • appropriate for gestational age
  • gestation age within 38 and 42 weeks

Exclusion Criteria:

  • chromosomal or congenital abnormalities

Preterm group

Inclusion Criteria:

  • birth weight less than 1,500 g
  • gestational age less than 37 weeks
  • admission at the hospitals within 7 days after birth

Exclusion Criteria:

  • chromosomal or congenital abnormalities

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

Cohorts and Interventions

Group / Cohort
preterm
Very-low-birth-weight preterm infants with brain lesion
full-term
Healthy fullterm infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral blood flow velocity
Time Frame: post-conceptional age=40 weeks
post-conceptional age=40 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal Neurobehavioral Examination
Time Frame: post-conceptional age=40 weeks
post-conceptional age=40 weeks

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Suh-Fang Jeng, Doctor, National Taiwan University

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

April 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 19, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200802011R

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.

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