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Brainstem and Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02669056
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : April 28, 2016
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: preterm babies
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
term babies with blood test prescription
Other: 5-HT measurement

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02669056

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Contact: Catherine GIRE, MD
Contact: Blandine BELLOT, MD

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Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France
Contact: Catherine Gire   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: Urielle Desalbres APHM

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02669056     History of Changes
Other Study ID Numbers: 2015-35
RCAPHM15_0265 ( Other Identifier: APHM )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: January 2016