Examining how preterm and term infants respond to new stimuli
Habituation's Mechanisms in Preterm and Term Infants. Behavioral Evaluation: APIB (Assessment of Preterm Infant's Behavior). Assessment of the Cortical and Vegetative Responses
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 |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 2 Days to 10 Weeks |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT02496104 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe neurological diseases, malformations, or those who have received certain medications shortly before the study may not benefit.
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 performed: While the specific approach of this study may be novel, similar studies have shown the importance of habituation in infant development.
Eligibility criteria
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 this trial is running
Brest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.