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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT00614744 Completed - Infant, Newborn Clinical Trials

Late Hypothermia for Hypoxic-Ischemic Encephalopathy

Start date: April 2008
Phase: N/A
Study type: Interventional

This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

NCT ID: NCT00593242 Completed - Clinical trials for Neonatal Hypoxic Ischemic Encephalopathy

Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

Start date: January 2008
Phase: Phase 1
Study type: Interventional

This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.

NCT ID: NCT00383305 Completed - Clinical trials for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)

CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

Start date: July 1999
Phase: N/A
Study type: Interventional

This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.

NCT ID: NCT00375908 Completed - Clinical trials for Hypoxia-Ischemia, Brain

Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

Start date: October 2005
Phase: N/A
Study type: Observational

The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls. After delivery an umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder of the cord blood is discarded. The investigators plan to use this cord blood that would otherwise be discarded to perform our proteomic analysis. The investigators will use up to 20 ml of cord blood per delivery. This will be a 5 year study during which time the investigators hope to analyze 450 infants at Johns Hopkins Hospital and Bayview Medical Center. The investigators will obtain an umbilical venous sample from infants born at < 34 weeks gestation. For infants born at > 34 weeks the investigators will obtain an umbilical venous sample for any infant suspected to be at risk for neurologic injury by having a diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the time of delivery, or a 5 minute Apgar < 7. For the infants born at < 34 weeks the brain injured infants will be compared to gestational age matched controls without brain injury. For the infants born at > 34 weeks, each infant later confirmed to have neurologic morbidity will be compared to a gestational age matched noninjured control. The investigators hope to use proteomic analysis to determine if there are measurable differences in protein expression between the 2 groups.

NCT ID: NCT00097097 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Neonatal Resuscitation in Zambia

Start date: October 2004
Phase: Phase 3
Study type: Interventional

Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

NCT ID: NCT00006516 Completed - Clinical trials for Hypoxia-Ischemia, Brain

Home Stimulation for Brain-Asphyxiated Infants

Start date: September 1999
Phase: Phase 2
Study type: Interventional

This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities. Progress will be evaluated through neurological and behavioral exams.

NCT ID: NCT00005772 Completed - Infant, Newborn Clinical Trials

Whole-Body Cooling for Birth Asphyxia in Term Infants

Start date: October 1999
Phase: Phase 3
Study type: Interventional

This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). The study was conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention. Surviving children were given neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7 years of age).