NCT03188107

Brief Summary

The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Status
unknown

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

August 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

June 13, 2017

Last Update Submit

November 22, 2017

Conditions

Keywords

Risky InfantCerebral PalsyDown SyndromeSpina BifidaInfant Motor Profile

Outcome Measures

Primary Outcomes (1)

  • Infant Motor Profile

    Video recording based assessment of motor status

    Infants will be assessed at baseline and 3 months later from the first assessment.

Study Arms (2)

Risky Infants

Infants that have risk of developing motor impairment, or infants diagnosed as Spina Bifida, Down Syndrome ect.

Other: Video based assessment

Healthy Infants

Healthy infants that have normal motor development

Other: Video based assessment

Interventions

All the infants included in this study will be assessed with Infant Motor Profile based on video recording.

Healthy InfantsRisky Infants

Eligibility Criteria

Age3 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Study population consists of risky infants (premature infants, low birth weighted infants, infants with spina bifida or down syndrome

You may qualify if:

  • Clinical Diagnosis of Cerebral Palsy
  • Clinical Diagnosis of Down Syndrome
  • Clinical Diagnosis of Spina Bifida

You may not qualify if:

  • Uncontrolled Epilepsy
  • Severe Congenital Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Heineman KR, Bos AF, Hadders-Algra M. Infant Motor Profile and cerebral palsy: promising associations. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:40-5. doi: 10.1111/j.1469-8749.2011.04063.x.

MeSH Terms

Conditions

Premature BirthCerebral PalsyDown SyndromeMetabolic DiseasesSpinal DysraphismBirth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornNutritional and Metabolic DiseasesNeural Tube DefectsNervous System MalformationsBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşe NUMANOĞLU AKBAŞ, PhD

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pt, PhD

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

November 24, 2017

Record last verified: 2017-11