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Completed

NCT Number: NCT02669056

Brainstem and Prematurity

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

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Key information

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-HT measurement

Other

cerebral MRI

Other

Video recording

Other

EEG

Other

growth curves

Other

ASQ questionnaire

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Respiratory pattern assessment

    Time frame: at 36 weeks

    Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…

  5. Ages and Stages Questionnaires (ASQ)

    Time frame: 12 and 24 month post-term age

    ASQ questionnaire as neurodevelopmental assessment will be send to parents

  6. weight and statural growth assessment

    Time frame: until 24 month postterm age

  7. statural growth assessment

    Time frame: until 24 month postterm age

  8. Hospitalization duration

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Jan 29, 2016
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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