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RecruitingNCT02496104

Habituation's Mechanisms in Preterm and Term Infants

Habituation's Mechanisms in Preterm and Term Infants. Behavioral Evaluation: APIB (Assessment of Preterm Infant's Behavior). Assessment of the Cortical and Vegetative Responses

Status
Recruiting
Phase
Study type
Observational
Enrollment
70 (estimated)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
2 Days – 10 Weeks
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALPackage n°1 of the APIB

Timeline

Start date
2015-07-09
Primary completion
2027-01-01
Completion
2029-01-01
First posted
2015-07-14
Last updated
2025-09-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02496104. Inclusion in this directory is not an endorsement.