An interventional study of 5-HT measurement and cerebral MRI in Very Premature Infants, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged Up to 28 Weeks. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
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
Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.
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Exclusion Criteria:
preterm babies (less than 28 weeks)
Other: 5-HT measurement · Other: cerebral MRI · Other: Video recording · Other: EEG · Other: growth curves · Other: ASQ questionnaire
term babies with blood test prescription
Other: 5-HT measurement
5-HT levels
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.
Time frame: term age (37 weeks)
Posterior fossa injury
MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa
Time frame: at term age (37 weeks)
General movements (GMs) assesment
GMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs
Time frame: 3 times in the hospitalization period and at 3 month post-term age
R-R variability assesment
The autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings
Time frame: at 36 weeks
Respiratory pattern assessment
Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…
Time frame: at 36 weeks
Ages and Stages Questionnaires (ASQ)
ASQ questionnaire as neurodevelopmental assessment will be send to parents
Time frame: 12 and 24 month post-term age
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
Ran from Dec 2015 to primary completion in Jan 2019, 36 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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