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CompletedNCT02669056Updated May 16, 2023

Brainstem and Prematurity

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

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
Up to 28 Weeks
Sex
All
01

Study 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

02

Conditions studied

  • Very Premature Infants
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Infant with congenital cardiopathy, congenital brainstem disorder, Pierre Robin sequence
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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

  • Other
    term babies

    term babies with blood test prescription

    Other: 5-HT measurement

Interventions

  • Other5-HT measurement
  • Othercerebral MRI
  • OtherVideo recording
  • OtherEEG
  • Othergrowth curves
  • OtherASQ questionnaire
06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Respiratory pattern assessment

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

    Time frame: at 36 weeks

  5. Ages and Stages Questionnaires (ASQ)

    ASQ questionnaire as neurodevelopmental assessment will be send to parents

    Time frame: 12 and 24 month post-term age

  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

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Marseille
    Marseille, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Jan 2019, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2016
First posted
Jan 29, 2016
StartActual
Dec 17, 2015
Primary completionActual
Jan 1, 2019
CompletionActual
May 12, 2023
Last update
May 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02669056
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Dec 17, 2015
Primary completion
Jan 1, 2019
Completion
May 12, 2023
Last update
May 16, 2023

Study contacts

Urielle Desalbres
study director · APHM

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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