Habituation's Mechanisms in Preterm and Term Infants (HABIPREMA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Habituation, Psychophysiological; Preterm, Infant
• Intervention / Treatment: Behavioral: Package n°1 of the APIB

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 2 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants and term infants born in Brest University Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants; Preterm infants born between 25 weeks and 32 weeks + 6 days of gestation	Behavioral: Package n°1 of the APIB; Other Names: Sound and light stimulations
Term newborns; Infant born at term	Behavioral: Package n°1 of the APIB; Other Names: Sound and light stimulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time Frame
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)
Ages and Stages Questionnaire	At 24 months old (corrected age for the preterm infants)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2015
• Primary Completion (ANTICIPATED): July 1, 2026
• Study Completion (ANTICIPATED): July 1, 2026

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (ESTIMATE): July 14, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Infant; Preterm; APIB; Habituation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Substance-Related Disorders; Premature Birth
• Other Study ID Numbers: HABIPREMA - RB 14.059