Clinical trial NCT02455830: Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy
Official title: A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
Keywords: Neonatal encephalopathy
Hypoxic-ischemic encephalopathy
Newborn infants
Cytokines
Trophic factors
Lead sponsor: Neonatal Encephalopathy Consortium, Japan
Sponsor class: NETWORK
Collaborators: name: Osaka City University
name: Yodogawa Christian Hospital
name: Kurashiki Central Hospital
name: Nagoya University
name: Osaka City General Hospital
name: Saitama Medical University
name: National Cerebral and Cardiovascular Center, Japan
name: National Center for Child Health and Development, Japan
name: Tokyo University
name: Tokyo Women's Medical University
First posted: 2015-05-28
Enrollment: 18
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with encephalopathy who meet the inclusion criteria of therapeutic hypothermia, either those who receive the cell therapy or those who do not.

Brief summary: This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

Detailed description: The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Eligibility criteria: Inclusion Criteria:

Infants are eligible if they meet all the following inclusion criteria except 4.

1. ≥36 weeks gestation
2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
3. Moderate to severe encephalopathy (Sarnat II to III)
4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
5. Up to 24 hours of age
6. A person with parental authority must have consented for the study.

Exclusion Criteria:

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe growth restriction, with birth-weight less than 1800 g
4. Severe infectious disease, such as sepsis
5. Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist

Primary outcomes:
measure: Changes in serum levels of cytokines and trophic factors
timeFrame: From birth up to 10 days of age
Secondary outcomes:
measure: Association with neuroimaging and neurodevelopmental functional outcome
timeFrame: 18 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
Study officials:
affiliation: Osaka City University Graduate School of Medicine
name: Haruo Shintaku, MD, PhD
role: STUDY_DIRECTOR
References: