Very Preterm InfantsProHémieNCT02007902
Plasma Protein Levels and Very Preterm Birth
An observational study of Very Preterm Infants, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in France.
Trial summary
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the… Read more about this study
- Who is it for?
- Ages 1 minute to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Very Preterm Infants
- What is being tested?
- Evaluation of the relationship plasma protein levels - neonatal hemodynamics
- How many people
- 125 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2014to Mar 2015
- Phase
- Observational
- 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 1 minute to 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Study population: Very preterm infants with birth at less than 32 weeks of gestational age
Who may be able to join
- Parents written informed consent
- Birth at less than 32 weeks of gestational age
- Birth in a III level delivery facility at Reunion Island
Who cannot join
- Major congenital abnormalities
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hopsitalier Universitaire de La Réunion
Saint-Denis, La Réunion, 97405
Centre Hospitalier de La Réunion
Saint-Pierre, La Réunion, 97448
About this study
Official title: Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
- Conditions
- Very Preterm Infants
- Being tested
- Evaluation of the relationship plasma protein levels - neonatal hemodynamics
- Keywords
- Preterm baby, Total plasma protein, Albumin, Hemodynamic disturbances, Perfusion, Near Infra Red Spectroscopy (NIRS), Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the relationship plasma protein levels - neonatal hemodynamicsOther
- Patient inclusion at birth
- Total plasma protein values measurement on cord blood sample at birth
- Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
- Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
- Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 [regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy] will be monitored over 24 hours after birth.
| Study group | Role | What they receive |
|---|---|---|
| Very preterm babies | Observational model: cohort Receives: Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS
Measured: about 6 hours after birth
Secondary outcomes (3)
plasma protein
plasma protein level on cord blood sample depending on maternal and neonatal variables
Measured: at 1 second after birth (cord blood sample)
Albumin level
Measured: At 12 hours after birth
Mortality rate
Measured: patients will be followed for the duration of hospital stay, that is an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM CIE1, Dijon, 21000, France
- Responsible party
- Sponsor
- Investigators
- Silvia Iacobelli, Principal investigator, CHU de La Réunion -Site du GHSRSylvain Samperiz, MD, Principal investigator, CHU de La Réunion - Hôpital Félix Guyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007902
- Sponsor's protocol ID
- 2013/CHU/02
- Other IDs
- 2013-A00090-45
- Acronym
- ProHémie
- Status last verified
- Sep 2018
- First submitted
- 25 Nov 2013
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT02007902
- Acronym / sponsor ID
- ProHémie / 2013/CHU/02
- Conditions
- Very Preterm Infants
- Keywords
- Preterm baby, Total plasma protein, Albumin, Hemodynamic disturbances, Perfusion, Near Infra Red Spectroscopy (NIRS), Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- INSERM CIE1, Dijon, 21000, France
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Dec 2013 (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.
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very preterm babies | – | Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamicsObservational model: cohort |
Who may qualify
- Ages
- 1 minute to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Very preterm infants with birth at less than 32 weeks of gestational age
Key inclusion criteria (3 listed)
- Parents written informed consent
- Birth at less than 32 weeks of gestational age
- Birth in a III level delivery facility at Reunion Island
Key exclusion criteria (1 listed)
- Major congenital abnormalities
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 |
|---|---|---|
| Evaluation of the relationship plasma protein levels - neonatal hemodynamics* Patient inclusion at birth * Total plasma protein values measurement on cord blood sample at birth * Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler * Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth * Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 [regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy] will be monitored over 24 hours after birth. | Other | Very preterm babies |
Primary outcome
Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS
Time frame: about 6 hours after birth
3 secondary outcomes
plasma protein
Time frame: at 1 second after birth (cord blood sample)
Albumin level
Time frame: At 12 hours after birth
Mortality rate
Time frame: patients will be followed for the duration of hospital stay, that is an average of 8 weeks
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 1 Oct 2018.
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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.
Silvia Iacobelli principal investigator
CHU de La Réunion -Site du GHSR
Sylvain Samperiz, MD principal investigator
CHU de La Réunion - Hôpital Félix Guyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Preterm Infants, run by Centre Hospitalier Universitaire de la Réunion at 2 sites 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 3 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS (time frame: about 6 hours after birth). 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 1 Oct 2018.