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Asphyxia clinical trials

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NCT ID: NCT00639184 Completed - Asphyxia Clinical Trials

BRAIN - Home Intervention Trial

BRAIN-HIT
Start date: June 2007
Phase: Phase 4
Study type: Interventional

We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. The trial will evaluate the effect of a resource-intensive early intervention (EI) program on the outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. The control group will receive enhanced health counseling (HC). The overall goal will be to implement and evaluate an EI program for infants following birth asphyxia, which is sustainable in developing countries. The challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. Because there are limited data on normative development and EI programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. A final aim will be to address individual variation in EI effects that could be due to child and/or family characteristics. A randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either EI or enhanced health education counseling (HC). The trial will randomize infants to a home-based parent-provided early developmental intervention (EI) with frequent home interaction between parents and parent trainers vs. HC. A group of infants without birth asphyxia or other major perinatal complications also will be randomized. Children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).

NCT ID: NCT00553072 Completed - Clinical trials for Perinatal Asphyxia , Moderate to Severe HIE

Magnesium Sulphate in Perinatal Asphyxia

Magsulf
Start date: September 2004
Phase: Phase 3
Study type: Interventional

Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.

NCT ID: NCT00494702 Completed - Premature Birth Clinical Trials

Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

OXTOX
Start date: April 2005
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.

NCT ID: NCT00491413 Not yet recruiting - Asphyxia Clinical Trials

Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth

Start date: n/a
Phase: Phase 1
Study type: Interventional

Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

NCT ID: NCT00147030 Completed - Hypoxia Clinical Trials

TOBY: a Study of Treatment for Perinatal Asphyxia

Start date: December 2002
Phase: N/A
Study type: Interventional

Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

NCT ID: NCT00136708 Completed - Asphyxia Neonatorum Clinical Trials

First Breath: Neonatal Resuscitation in Developing Countries

Start date: March 2005
Phase: N/A
Study type: Interventional

In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

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: NCT00062452 Completed - Clinical trials for Infant, Premature, Diseases

Esophageal Motility and Airway Defenses Among Infants

Start date: May 2002
Phase: N/A
Study type: Observational

Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.