Very Premature InfantsNCT02669056
Brainstem and Prematurity
A study testing 5-HT measurement, cerebral MRI and Video recording in people with Very Premature Infants, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 weeks
- Conditions the study is for
- Very Premature Infants
- What is being tested?
- 5-HT measurement, cerebral MRI and Video recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2015to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Infant with congenital cardiopathy, congenital brainstem disorder, Pierre Robin sequence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brainstem Assesment in a Cohort of Very Preterm Babies (Less Than 28 Weeks)
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.
Read more
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
- Being tested
- 5-HT measurement, cerebral MRI, Video recording, EEG, growth curves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-HT measurementOther
cerebral MRIOther
Video recordingOther
EEGOther
growth curvesOther
ASQ questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| preterm babies | Experimental | preterm babies (less than 28 weeks) Receives: 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 Receives: Other: 5-HT measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: term age (37 weeks)
Secondary outcomes (8)
Posterior fossa injury
MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa
Measured: at term age (37 weeks)
General movements (GMs) assesment
GMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs
Measured: 3 times in the hospitalization period and at 3 month post-term age
R-R variability assesment
The autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings
Measured: at 36 weeks
Respiratory pattern assessment
Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…
Measured: at 36 weeks
Ages and Stages Questionnaires (ASQ)
ASQ questionnaire as neurodevelopmental assessment will be send to parents
Measured: 12 and 24 month post-term age
weight and statural growth assessment
Measured: until 24 month postterm age
statural growth assessment
Measured: until 24 month postterm age
Hospitalization duration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start17 Dec 2015
- Primary completion1 Jan 2019
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Premature InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669056
- Sponsor's protocol ID
- 2015-35
- Other IDs
- RCAPHM15_0265
- Status last verified
- May 2023
- First submitted
- 27 Jan 2016
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brainstem Assesment in a Cohort of Very Preterm Babies (Less Than 28 Weeks)
- ClinicalTrials.gov ID
- NCT02669056
- Acronym / sponsor ID
- 2015-35
- Conditions
- Very Premature Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm babies | Experimental | Other: 5-HT measurement, Other: cerebral MRI, Other: Video recording, Other: EEG, Other: growth curves, Other: ASQ questionnairepreterm babies (less than 28 weeks) |
| term babies | Other | Other: 5-HT measurementterm babies with blood test prescription |
Who may qualify
- Ages
- Up to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Infant with congenital cardiopathy, congenital brainstem disorder, Pierre Robin sequence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
8 secondary outcomes
Posterior fossa injury
Time frame: at term age (37 weeks)
General movements (GMs) assesment
Time frame: 3 times in the hospitalization period and at 3 month post-term age
R-R variability assesment
Time frame: at 36 weeks
Respiratory pattern assessment
Time frame: at 36 weeks
Ages and Stages Questionnaires (ASQ)
Time frame: 12 and 24 month post-term age
weight and statural growth assessment
Time frame: until 24 month postterm age
statural growth assessment
Time frame: until 24 month postterm age
Hospitalization duration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle Desalbres study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-HT measurement, cerebral MRI and Video recording in people with Very Premature Infants, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-HT levels (time frame: term age (37 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.