Brainstem and Prematurity

NCT02669056 | Completed

• 2 other identifiers: 2015-35RCAPHM15_0265
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Very Premature Infants

Outcome Measures

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.

  term age (37 weeks)

Secondary Outcomes (8)

• Posterior fossa injury

  at term age (37 weeks)

• General movements (GMs) assesment

  3 times in the hospitalization period and at 3 month post-term age

• R-R variability assesment

  at 36 weeks

• Respiratory pattern assessment

  at 36 weeks

• Ages and Stages Questionnaires (ASQ)

  12 and 24 month post-term age

Study Arms (2)

preterm babies

EXPERIMENTAL

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

OTHER

term babies with blood test prescription

Other: 5-HT measurement

Interventions

5-HT measurement OTHER

preterm babies; term babies

cerebral MRI OTHER

preterm babies

Video recording OTHER

preterm babies

EEG OTHER

preterm babies

growth curves OTHER

preterm babies

ASQ questionnaire OTHER

preterm babies

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Interventions

Videotape Recording; Growth Charts

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Reference Standards; Weights and Measures; Investigative Techniques

Study Officials

• Urielle Desalbres

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: December 17, 2015
• Primary Completion: January 1, 2019
• Study Completion: May 12, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

FR (1)