NCT01514747

Brief Summary

Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long-term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

6.8 years

First QC Date

January 18, 2012

Last Update Submit

July 11, 2019

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • MRI

    0

Study Arms (1)

ELBW infants

Eligibility Criteria

Age2 Months - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ELBW infants with birth weight 401-1000 g (gestational age \<30 weeks)

You may qualify if:

  • ELBW infants with birth weight 401-1000 g (gestational age \<30 weeks)

You may not qualify if:

  • Complex congenital anomalies
  • Central nervous system malformations,
  • Chromosomal abnormalities, or hydrops fetalis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

October 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

US(1)