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NCT Number: NCT02496104

Habituation's Mechanisms in Preterm and Term Infants

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.

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Key information

Age range

2 day–10 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Location status: Recruiting

Location contact

Jean-Michel ROUE, Professor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Package n°1 of the APIB

Behavioral

Other names: Sound and light stimulations

Primary outcomes

  1. Assessment of the package n°1 of the APIB (Assessment of Premature Infant's Behaviour)

    Time frame: At 40 weeks of postnatal gestational age for the preterm infants and at 3 days old for the term newborns

Secondary outcomes

  1. Salivary cortisol changes

    Time frame: Before and 30 minutes after the package n°1 of the APIB achievement

  2. Oxy and deoxyhemoglobin changes in NIRS (Near-infrared Spectroscopy)

    Time frame: During APIB package n°1 fulfillment

  3. Heart rate variations

    Time frame: During APIB package n°1 fulfillment

  4. Oxymetry variations

    Time frame: During APIB package n°1 fulfillment

  5. Brief Infant Sleep Questionnaire

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

  6. Ages and Stages Questionnaire

    Time frame: At 24 months old (corrected age for the preterm infants)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Michel ROUE, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: HABIPREMA

Important dates

Study start
2015
Primary completion
2027
Study completion
2029
First posted
Jul 14, 2015
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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