Habituation's Mechanisms in Preterm and Term Infants

NCT ID: NCT02496104

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-09
• Study Completion Date: 2029-01-31

Brief Summary

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

Habituation, Psychophysiological; Preterm, Infant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm infants

Preterm infants born between 25 weeks and 32 weeks + 6 days of gestation

Package n°1 of the APIB

Intervention Type: BEHAVIORAL

Term newborns

Infant born at term

Package n°1 of the APIB

Intervention Type: BEHAVIORAL

Interventions

Package n°1 of the APIB

Intervention Type: BEHAVIORAL

Other Intervention Names

Sound and light stimulations

Eligibility Criteria

Inclusion Criteria

• Preterm infants: preterm infants born from 25 weeks to 32 weeks + 6 days of gestation near to 36 weeks of gestation (corrected postnatal age)
• Term infants: term newborns with a gestational age between 39 and 41 weeks of gestation at day 3 with an Apgar ≥ 1 at 1 minute of life
• For both groups: normal neurological physical examination, written informed consent of the parents

Exclusion Criteria

• no malformation or chromosomal abnormality, life threatening disease, administration of morphine or sedatives during the 24 hours before the study, context of maternal drug addiction, deafness, no psychoactive drug or anticonvulsivants during the last month of pregnancy for the term newborns, severe neurological disease

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel ROUE, Professor

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

CHRU de Brest

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Michel ROUE, Professor

Role: CONTACT

jean-michel.roue@chu-brest.fr

Facility Contacts

Jean-Michel ROUE, Professor

Role: primary

jean-michel.roue@chu-brest.fr

Other Identifiers

29BRC14.0059

Identifier Type: -

Identifier Source: org_study_id