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Tests treatment safety and results for Neonatal Hypoxic-ischaemic Encephalopathy
Official title Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
ClinicalTrials.gov ID: NCT02881970
What this study is testing
What is autologous cord blood stem cell?
autologous cord blood stem cell is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neonatal hypoxic-ischaemic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 3
You may be able to join if
- Term ≥ 36 weeks of gestation
- and (2) :
- a blood pH \ 12 mmol/l (at birth or within 60 minutes of age)
- or a blood pH between 7,01 and 7,15, with additionnal criteria:
- a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage)
You likely can't join if
- presence of known chromosomal anomaly.
- presence of major congenital anomalies. severe intrauterine growth restriction (weight \<1800g)
- infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
See the full eligibility criteria
- Term ≥ 36 weeks of gestation
- and (2) :
- a blood pH \ 12 mmol/l (at birth or within 60 minutes of age)
- or a blood pH between 7,01 and 7,15, with additionnal criteria:
- a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage)
- and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth.
- signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2)
- ± abnormal electroencephalogram or aEEG within 12 hours of age
- therapeutic hypothermia.
- no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus.
- maternal negative serology for syphilis
- written parental consent
- presence of known chromosomal anomaly.
- presence of major congenital anomalies. severe intrauterine growth restriction (weight \<1800g)
- infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 3 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.