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Brainstem and Prematurity

Brainstem Assesment in a Cohort of Very Preterm Babies (Less Than 28 Weeks)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02669056
Enrollment
34
Registered
2016-01-29
Start date
2015-12-17
Completion date
2023-05-12
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Premature Infants

Brief summary

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

Interventions

OTHER5-HT measurement
OTHEREEG
OTHERgrowth curves
OTHERASQ questionnaire

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Weeks
Healthy volunteers
No

Inclusion criteria

* Birth less than 28 weeks * known gestational age * Birth in born * Infant without genetic syndrom, evolutive neurologic disease, chronic disorder, malformative pathology * Infant without intra-ventricular haemorrhage with dilatation or intraparenchymal haemorrhage * Infants without mechanical ventilation

Exclusion criteria

• Infant with congenital cardiopathy, congenital brainstem disorder, Pierre Robin sequence

Design outcomes

Primary

MeasureTime frameDescription
5-HT levelsterm 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.

Secondary

MeasureTime frameDescription
General movements (GMs) assesment3 times in the hospitalization period and at 3 month post-term ageGMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs
R-R variability assesmentat 36 weeksThe autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings
Respiratory pattern assessmentat 36 weeksRespiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…
Posterior fossa injuryat term age (37 weeks)MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa
weight and statural growth assessmentuntil 24 month postterm age
statural growth assessmentuntil 24 month postterm age
Hospitalization duration6 months
Ages and Stages Questionnaires (ASQ)12 and 24 month post-term ageASQ questionnaire as neurodevelopmental assessment will be send to parents

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026