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Clinical Trial - Omega-3 Fatty Acid supplementation to Prevent Preterm Birth in High Risk Pregnancies - A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy.

The National Birth Defects Prevention Network (NBDPN) is a group of individuals involved in birth defects surveillance, research, and prevention. It was created to establish and maintain a national network of state and population-based programs for birth defects surveillance and research. The Network assesses the impact of birth defects upon children, families, and health care; identifies factors that can be used to develop primary prevention strategies; and assists families and their providers in secondary disabilities prevention.

PubMed Study Abstract: Ten indicators available during the first two hours of life, such as clinical criteria of neonatal distress and postnatal arterial blood gases, were compared with the neonatal neurological course in sixty full term newborns with significant birth asphyxia in order to test their value for the diagnosis and the short-term prognosis of severe birth asphyxia. Birth asphyxia was defined as severe when it was followed by symptoms of moderate or severe post-asphyxial encephalopathy.

eMedicine - Birth Trauma - Birth Injury risks and information

The Merck Manuals Online Medical Library - Information and causes of birth injury

PubMed Study Abstract - A retrospective analysis of 8,839 singleton deliveries was undertaken to determine the relationships of maternal age, maternal hemoglobin concentrations, and past obstetric performance to the incidence of low-birth-weight (LBC) deliveryct: Patients at high risk for low-birth-weight delivery.

PRIMARY OBJECTIVE of study is to determine whether cerebral outcome is improved if infants born between 24 0/7 and 31 6/7 gestational weeks at birth receive erythropoietin in high dose in the first three days after birth. SECONDARY OBJECTIVES To determine whether early administration of EPO alters the incidence of complications typically associated with preterm birth, i.e. mortality, septicaemia, necrotising enterocolitis, bronchopulmonary dysplasia (oxygen dependency at 36 weeks postmenstrual age), retinopathy, intracranial haemorrhage, white matter disease (periventricular leucomalacia), growth failure, cerebral palsy and handicap at 5 years.

Completed study. In this feasibility study, hyperoxemia, as proximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of ulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth. This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease. Our study will investigate how adjusting the amount of oxygen given to sick preterm newborns will affect the ability to maintain a safe oxygen level in their blood

Hypothesis of study is that among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: Twin pregnancy - Triplet pregnancy

2009 School of Medicine, University of Mostar, Bosnia and Herzegovina Study to investigate the risk factors associated with Cerebral Palsy

Neonatal outcomes of late-preterm birth associated or not with intrauterine growth restriction.Conclusion. Our study showed that late-preterm IUGR infants present a significantly higher risk of neonatal complications when compared to late-preterm AGA infants.

Acute birth asphyxia is a cause of death and neurological injury. At present, there is no proven treatment; however, studies in animals suggest that brain cooling may protect against brain injury. This large multicenter trial will randomize term infants with a history of problems at delivery and signs of depression to total body cooling or standard care.

PubMed.gov Study Abstract - Study to identify neonatal risk factors for cerebral palsy among very preterm babies and in particular the associations independent of the coexistence of antenatal and intrapartum factors.

Wiley Interscience - Study - Assessing the contribution of birth asphyxia to cerebral palsy in term singletons

A recent study using high-dose rhEpo (3000 U rhEpo/kg body weight at birth) for neuroprotection in very preterm infants revealed that no signs of adverse effects of early high-dose rhEpo treatment in very preterm infants were identified. Contrary to this, a recent study in PVL of a rat model revealed that using a low dose rhEpo (50-100 U/kg) was effective in the treatment of brain damage induced by hypoxia-ischemia and did not affect normal oligodendrocyte maturity. On this basis, the researchers intent to investigate (1) whether low-dose rhEpo (100 U/kg) or high-dose rhEpo (3,000 U/kg) given to very preterm infants (gestation age < 32 weeks) immediately after birth and subsequently during the first 2 days is safe and possesses neuroprotective properties;(2) whether there are gender differences in response to the hypoxia-ischemic insult and EPO treatment; (3)the pharmacokinetics of low dose and high dose rhEPO.

Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the actual temperature of the brain. This will enable researchers to determine if the brain is being uniformly cooled and if techniques that provide cooling need to be changed to improve the injury prevention from cooling

Observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.

NIH PubMed Central Archives of Disease in Childhood - Umbilical venous blood ph: a useful aid in the diagnosis of asphyxia at birth. Umbilical venous blood, and umbilical arterial blood pH, PO2, PCO2, and base excess were determined in 453 term infants at birth. The results indicate that umbilical venous blood pH, and umbilical arterial blood pH are significantly related to each another.

Ongoing study sponsored by NICHD will compare the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, will have a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study will determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.