Actively Recruiting

Age: 2Days - 10Weeks
All Genders
Healthy Volunteers
NCT02496104

Habituation's Mechanisms in Preterm and Term Infants

Led by University Hospital, Brest · Updated on 2025-09-16

70

Participants Needed

1

Research Sites

703 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.

CONDITIONS

Official Title

Habituation's Mechanisms in Preterm and Term Infants

Who Can Participate

Age: 2Days - 10Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born from 25 weeks to 32 weeks plus 6 days of gestation near 36 weeks corrected postnatal age
  • Term newborns with gestational age between 39 and 41 weeks at day 3 with Apgar score of 1 or higher at 1 minute
  • Normal neurological physical examination for all infants
  • Written informed consent from parents
Not Eligible

You will not qualify if you...

  • Presence of malformations or chromosomal abnormalities
  • Life-threatening disease
  • Use of morphine or sedatives within 24 hours before the study
  • Maternal drug addiction context
  • Deafness
  • Use of psychoactive drugs or anticonvulsants during the last month of pregnancy for term newborns
  • Severe neurological disease

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Trial Site Locations

Total: 1 location

1

CHRU de Brest

Brest, France, 29609

Actively Recruiting

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Research Team

J

Jean-Michel ROUE, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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