Habituation's Mechanisms in Preterm and Term Infants

NCT02496104 | Recruiting DMC

• 1 other identifier: 29BRC14.0059
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Preterm; Infant; Habituation; APIB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Salivary cortisol changes

  Before 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 variations

  During APIB package n°1 fulfillment

• Oxymetry variations

  During APIB package n°1 fulfillment

• Brief Infant Sleep Questionnaire

  At 6 and 12 months old (corrected age for the preterm infants)

Study Arms (2)

Preterm infants

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

Behavioral: Package n°1 of the APIB

Term newborns

Infant born at term

Behavioral: Package n°1 of the APIB

Interventions

Package n°1 of the APIB BEHAVIORAL

Also known as: Sound and light stimulations

Preterm infants; Term newborns

Eligibility Criteria

• Age: 2 Days - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants and term infants born in Brest University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Premature Birth

Interventions

Sound

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jean-Michel ROUE, Professor

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Michel ROUE, Professor

CONTACT

jean-michel.roue@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: July 9, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)