NCT02908113

Brief Summary

We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life. A secondary aim is to compare this competencies in preterm and full term control art term equivalent age. The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants. Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

August 26, 2016

Last Update Submit

October 16, 2017

Conditions

Pediatrics

Outcome Measures

Primary Outcomes (2)

  • visual stimulus detection with luminance

    in "green" condition in hospital, luminance ( 100 and 300 lux ) and color (blue- red-yellow- white) variables

    3 months

  • auditory stimulus detection with parents voice

    use parents voice, pure sound of 500 Hz

    3 months

Secondary Outcomes (1)

  • behavioral responsiveness to visual stimuli calibrated collected from video recordings

    3 months

Study Arms (2)

preterm infants

OTHER

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

Behavioral: collection dataBehavioral: IRM

term infants

OTHER

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

Behavioral: collection dataBehavioral: IRM

Interventions

collection dataBEHAVIORAL
preterm infantsterm infants
IRMBEHAVIORAL
preterm infantsterm infants

Eligibility Criteria

Age23 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn less than 32 weeks PMA hospitalized in the Hospital of Hautepierre, Strasbourg, France)
  • Consent obtained from both parents
  • Social insurance coverage

You may not qualify if:

  • Any known malformation
  • Brain lesions discovered on brain ultrasound (Intra-Ventricular hemorrhage grade III or IV periventricular Leukomalacia).
  • Unstable clinical State
  • Retinopathy Of Prematurity stage\> 2 or in zone 1
  • Family history of abnormal color vision.
  • Abnormalities in auditory testing
  • Transfer to another hospital expected before 40 week PMA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôiptaux Universitaires

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Claire KOENIG ZORES, MD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire KOENIG ZORES, MD

CONTACT

03.88.12.77.86claire.KOENIG@chru-strasbourg.fr

Pierre KUHN, MD

CONTACT

03 88 12 77 76Pierre.Kuhn@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 20, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 17, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)