CompletedNot Applicable

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

Taiwan1 participantsStarted 2008-04

Plain-language 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. 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.

Who can participate

Age range

7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebral blood flow velocity

Timeframe: post-conceptional age=40 weeks

Trial details

NCT IDNCT00676247

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-05

View on ClinicalTrials.gov More Premature Birth trials