Habituation, PsychophysiologicalHABIPREMANCT02496104
Habituation's Mechanisms in Preterm and Term Infants
An observational study of Habituation, Psychophysiological and Preterm, Infant, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 days to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Habituation, Psychophysiological, Preterm, Infant
- What is being tested?
- Package n°1 of the APIB
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2015to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants and term infants born in Brest University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Michel ROUE, Professor contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Jean-Michel ROUE, Professor, jean-michel.roue@chu-brest.fr
About this study
Official 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
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
- Being tested
- Package n°1 of the APIB
- Keywords
- Preterm, Infant, Habituation, APIB
- Medical subject headings
- Substance-Related Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package n°1 of the APIBBehavioural
Also called Sound and light stimulations
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Preterm infants born between 25 weeks and 32 weeks + 6 days of gestation Receives: Behavioral: Package n°1 of the APIB | |
| Term newborns | Infant born at term Receives: Behavioral: Package n°1 of the APIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the package n°1 of the APIB (Assessment of Premature Infant's Behaviour)
Measured: 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
Measured: Before and 30 minutes after the package n°1 of the APIB achievement
Oxy and deoxyhemoglobin changes in NIRS (Near-infrared Spectroscopy)
Measured: During APIB package n°1 fulfillment
Heart rate variations
Measured: During APIB package n°1 fulfillment
Oxymetry variations
Measured: During APIB package n°1 fulfillment
Brief Infant Sleep Questionnaire
Measured: At 6 and 12 months old (corrected age for the preterm infants)
Ages and Stages Questionnaire
Measured: At 24 months old (corrected age for the preterm infants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start9 Jul 2015
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Habituation, PsychophysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel ROUE, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496104
- Sponsor's protocol ID
- 29BRC14.0059
- Acronym
- HABIPREMA
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02496104
- Acronym / sponsor ID
- HABIPREMA / 29BRC14.0059
- Conditions
- Habituation, Psychophysiological, Preterm, Infant
- Keywords
- Preterm, Infant, Habituation, APIB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Behavioral: Package n°1 of the APIBPreterm infants born between 25 weeks and 32 weeks + 6 days of gestation |
| Term newborns | – | Behavioral: Package n°1 of the APIBInfant born at term |
Who may qualify
- Ages
- 2 days to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants and term infants born in Brest University Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Package n°1 of the APIBAlso: Sound and light stimulations | Behavioural | Preterm infants, Term newborns |
Primary outcome
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
6 secondary outcomes
Salivary cortisol changes
Time frame: Before and 30 minutes after the package n°1 of the APIB achievement
Oxy and deoxyhemoglobin changes in NIRS (Near-infrared Spectroscopy)
Time frame: During APIB package n°1 fulfillment
Heart rate variations
Time frame: During APIB package n°1 fulfillment
Oxymetry variations
Time frame: During APIB package n°1 fulfillment
Brief Infant Sleep Questionnaire
Time frame: At 6 and 12 months old (corrected age for the preterm infants)
Ages and Stages Questionnaire
Time frame: At 24 months old (corrected age for the preterm infants)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Michel ROUE, Professor contact
Jean-Michel ROUE, Professor principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Habituation, Psychophysiological and Preterm, Infant, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Michel ROUE, Professor (jean-michel.roue@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.