NCT02880696

Brief Summary

A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. They also allow us to establish harmonious social interactions, coordinating us with our interlocutor during an exchange. Our ability to form temporal expectations seems to emerge very early but the development of this process is unknown. We only know that a set of basic skills, probably related to that ability, are present from birth. This suggests that temporal processing capabilities emerge during the prenatal period, but this has not been studied. The objective of this project is to study preterm infants brain's ability to process the intervals between stimuli and to form expectations on that basis.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 9, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 26, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

February 9, 2016

Last Update Submit

August 23, 2016

Conditions

Premature Birth

Keywords

Time PerceptionTactile PerceptionSpectroscopy, Near-Infrared

Outcome Measures

Primary Outcomes (1)

  • Activation of the primary somatosensory cortex during stimulation omissions

    Between 32 and 35 week of corrected gestational age

Secondary Outcomes (2)

  • Change in amplitude or time to peak of the response as a function of age

    Between 32 and 35 week of corrected gestational age

  • Change in amplitude or time to peak of the response with age as a function of vigilance state

    Between 32 and 35 week of corrected gestational age

Study Arms (2)

Test (Regular)

EXPERIMENTAL

Regular stimulation sequence \& DCS

Behavioral: Regular stimulation sequenceDevice: DCS

Control (Random)

ACTIVE COMPARATOR

Random stimulation sequence \& DCS

Behavioral: Random stimulation sequenceDevice: DCS

Interventions

Regular stimulation sequenceBEHAVIORAL

Vibrotactile stimulation of the right hand with regular intervals and random omissions

Test (Regular)
Random stimulation sequenceBEHAVIORAL

Vibrotactile stimulation of the right hand with random intervals and random omissions

Control (Random)
DCSDEVICE

Near-infrared imaging of the neurovascular response in the left somatosensory cortex

Also known as: Diffuse correlation spectroscopy
Control (Random)Test (Regular)

Eligibility Criteria

AgeUp to 6 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • premature infants born to SA 31 + 0 days to 32 weeks + 6 days , hospitalized in the neonatal unit of the University Hospital of Caen

You may not qualify if:

  • Suspected neurological disorder (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia), or motor condition that might interfere with tactile perception on the hand
  • Intubation or CPAP
  • Viral of bacterial infection
  • Sedation at the time of measurement
  • Parent(s) who are minor or unable to give free and informed consent
  • No consent from the parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nadège RN Roche-Labarbe, PhD

    Université Caen Normandie

    STUDY CHAIR

Central Study Contacts

Bernard GB Guillois, MD

CONTACT

02.31.27.25.64guillois-b@chu-caen.fr

Cathy GC Gaillard

CONTACT

02 31 06 53 49gaillard-c@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

August 26, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2018

Last Updated

August 26, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share