Examining how preterm and term infants respond to new stimuli
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
Run by University Hospital, Brest · NCT02496104 · Data updated 2026-11-12
This study looks at how preterm and full-term babies react to new sounds and lights to see if understanding their responses can help improve care for very preterm infants at risk of brain problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Days to 10 Weeks |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Status | Recruiting |
| Started | July 9, 2015 |
| Main results expected | January 2027 |
| Study ends | January 2029 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT02496104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include preterm infants born between 25 weeks to 32 weeks and term infants born between 39 to 41 weeks of gestation.
✕Probably not a fit
Patients with severe neurological diseases, malformations, or those who have received certain medications shortly before the study may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on understanding the mechanisms of habituation in preterm and term infants. It aims to assess how these infants become familiar with environmental stimuli, such as noise and light, which is crucial for their development. By identifying early signs of habituation, the study seeks to improve early interventions for very preterm infants who are at risk of neurological complications. The research involves infants born between 25 weeks to 32 weeks and term infants born between 39 to 41 weeks of gestation, with careful monitoring of their neurological health.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification of preterm infants at risk for developmental issues, allowing for timely interventions.
How similar studies have gone: While the specific approach of this study may be novel, similar studies have shown the importance of habituation in infant development.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHRU de Brest
Brest, France Recruiting
Study contacts
- Principal investigator: Jean-Michel ROUE, Professor — CHRU de Brest
- Study coordinator: Jean-Michel ROUE, Professor
- Email: jean-michel.roue@chu-brest.fr
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
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This initiative tests a nutrition bundle—personalized breast milk feeding, early zinc supplementation, and routine carnitine supplementation—for very preterm babies to see if it improves growth and development.
-
Using bubble CPAP sounds to measure airway pressure in premature infants
This project will try to see if the sounds made by bubble CPAP can tell us how much airway pressure very premature infants (born before 32 weeks) are actually receiving.
-
Early lung development in preterm babies with and without fetal growth restriction
This study will test whether ultrasound measurements of fetal lung volume, diaphragm thickness and heart function before 32 weeks can help predict breathing problems and later lung function in preterm babies with or without fetal growth restriction.
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This study is testing a new breathing support method for very preterm infants to see if it helps them do better in the short and long term.
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Positive feeding for preterm babies
This study will try a cue-based, parent-led feeding approach for preterm infants in the NICU to see if it can be put into practice and is acceptable to parents and staff.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.