Brainstem and Prematurity
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|ClinicalTrials.gov Identifier: NCT02669056|
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : April 28, 2016
Although significant advances in neonatal care have increased survival rates of preterm infants born before 28 weeks gestation, a concomitant decrease in neuro developmental disorders has not been achieved. Cerebral injuries, well documented during the previous years, in preterm babies are particularly deleterious since they occur in a developing brain. They affect both white and grey matter by complex mechanisms and the principal targets are the developing oligodendrocytes and neurons of the subplate. All these criteria define the encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of the brainstem are not very well known and may explain neuro-developmental disorders with normal MRI.
The assessment of the motor repertoire is complementary to the neurological examination and may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the development due to the feedback that they send to cortical neurons and reflect the maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by prematurity may induce alterations of the motor repertoire.
Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently in very preterm babies reflect brainstem abnormalities. These symptoms are also described in other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these pathologies deficits of the 5-HT system have been described and associated with dysautonomia. It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm babies.
The serotonergic system develops very early during gestation and is one of the first neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the respiratory network. Moreover, previous studies have shown that 5-HT projections to the spinal cord are involved in posture and in the coordination. It is tempting to think that 5-HT deficits may have some repercussions on the development of the CNS, changing activity dependent processes, such as spontaneous activity recorded at the spinal level in rodents.
In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior fossa, GMs and dysautonomia different parameters such as heart rate variability, suction-swallowing and different breathing techniques will be established
|Condition or disease||Intervention/treatment||Phase|
|Very Premature Infants||Other: 5-HT measurement Other: cerebral MRI Other: Video recording Other: EEG Other: growth curves Other: ASQ questionnaire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brainstem Assesment in a Cohort of Very Preterm Babies (Less Than 28 Weeks)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: preterm babies
preterm babies (less than 28 weeks)
Other: 5-HT measurement
Other: cerebral MRI
Other: Video recording
Other: growth curves
Other: ASQ questionnaire
term babies with blood test prescription
Other: 5-HT measurement
- 5-HT levels [ Time Frame: term age (37 weeks) ]5-HT platelets levels will be measured in very preterm and in term infants and compared (5-HT platelets level reflect the central 5HT level.
- Posterior fossa injury [ Time Frame: at term age (37 weeks) ]MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa
- General movements (GMs) assesment [ Time Frame: 3 times in the hospitalization period and at 3 month post-term age ]GMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs
- R-R variability assesment [ Time Frame: at 36 weeks ]The autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings
- Respiratory pattern assessment [ Time Frame: at 36 weeks ]Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…
- Ages and Stages Questionnaires (ASQ) [ Time Frame: 12 and 24 month post-term age ]ASQ questionnaire as neurodevelopmental assessment will be send to parents
- weight and statural growth assessment [ Time Frame: until 24 month postterm age ]
- statural growth assessment [ Time Frame: until 24 month postterm age ]
- Hospitalization duration [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669056
|Contact: Catherine GIRE, MDfirstname.lastname@example.org|
|Contact: Blandine BELLOT, MDemail@example.com|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Contact: Catherine Gire firstname.lastname@example.org|
|Study Director:||Urielle Desalbres||APHM|