NCT00676247

Brief 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. 1.to examine the hemodynamics of cerebral arteries in full-term and very low birth weight preterm infants at term age
  2. 2.to assess the validity of the hemodynamic parameters in relation to concurrent neurobehavioral function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

1 month

First QC Date

May 7, 2008

Last Update Submit

January 19, 2009

Conditions

Premature Birth

Keywords

UltrasonographyDopplerHemodynamicsNeurobehavioral development

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow velocity

    post-conceptional age=40 weeks

Secondary Outcomes (1)

  • Neonatal Neurobehavioral Examination

    post-conceptional age=40 weeks

Study Arms (2)

preterm

Very-low-birth-weight preterm infants with brain lesion

full-term

Healthy fullterm infants

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborns in the primary care clinic

You may qualify if:

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

You may not qualify if:

  • chromosomal or congenital abnormalities
  • Preterm group
  • birth weight less than 1,500 g
  • gestational age less than 37 weeks
  • admission at the hospitals within 7 days after birth
  • chromosomal or congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Suh-Fang Jeng, Doctor

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 12, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

TW(1)