Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02496104
Acronym
HABIPREMA
Enrollment
70
Registered
2015-07-14
Start date
2015-07-09
Completion date
2029-01-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Habituation, Psychophysiological, Preterm, Infant

Keywords

Preterm, Infant, Habituation, APIB

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.

Interventions

BEHAVIORALPackage n°1 of the APIB

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Days to 10 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Assessment of the package n°1 of the APIB (Assessment of Premature Infant's Behaviour)At 40 weeks of postnatal gestational age for the preterm infants and at 3 days old for the term newborns

Secondary

MeasureTime frame
Salivary cortisol changesBefore and 30 minutes after the package n°1 of the APIB achievement
Oxy and deoxyhemoglobin changes in NIRS (Near-infrared Spectroscopy)During APIB package n°1 fulfillment
Heart rate variationsDuring APIB package n°1 fulfillment
Oxymetry variationsDuring APIB package n°1 fulfillment
Brief Infant Sleep QuestionnaireAt 6 and 12 months old (corrected age for the preterm infants)
Ages and Stages QuestionnaireAt 24 months old (corrected age for the preterm infants)

Countries

France

Contacts

CONTACTJean-Michel ROUE, Professor
jean-michel.roue@chu-brest.fr
PRINCIPAL_INVESTIGATORJean-Michel ROUE, Professor

CHRU de Brest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026