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NICHD Neonatal Research Network and Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, initiated the Neonatal Research Network to conduct multi-center clinical trials and observational studies in neonatal medicine.

NICHD Neonatal Research Network

Article abstract of French study assessing neonatal outcomes after instrumental vaginal delivery. Many of the most severe neonatal complications are observed when perinatal asphyxia has occurred. Extractor types and quality of use under defined criteria are closely associated with neonatal adverse outcomes in operative vaginal delivery. Forceps deliveries are as safe as vacuum deliveries to the neonate. In conclusion, operative vaginal delivery performed for maternal or fetal reasons are associated with several neonatal adverse events, usually non specific and with a short term good prognosis.

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

Completed study sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD and 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

To evaluate the safety and multi-dose pharmacokinetics and dose ranging of intravenous followed by enteral myo-inositol (inositol) given at three dosage levels in extremely preterm neonates.

Study to demonstrate beneficial effects of parenteral carnitine supplementation in premature neonates for liver, heart and muscle metabolism and functions.

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

University of Medicine & Dentistry of New Jersey 2007 Study documents Widespread Repair of Neonatal Brain Injury from Adult Stem Cells - Neuroscientists at UMDNJ-New Jersey Medical School have discovered that the neonatal brain possesses a previously unknown capacity to replace damaged neurons in multiple brain regions. Furthermore, their research reveals that the production of these new neurons lasts for at least five months following injury.Levison's study reveals that in addition to neurons acquiring new or different responsibilities, that another adaptive response, one that has not been suspected, occurs. Their data show that large numbers of new neurons are produced from the brain's resident stem cells during their recovery from injury. These findings suggest that these new neurons are further increasing the infant brain's ability to repair itself after injury.

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.

The Fern Lab - The Fern lab is located in the Department of Neurology at the University of Washington in Seattle. The lab's research focuses on ischemic injury of the brain, in particular the neonatal/developing brain. Ischemia is the term given to a loss of blood supply and can arise due to obstruction of a blood vessel (leading to a stroke), or from factors that are currently not well understood but which produce the brain injury that underlies cerebral palsy.

Future planned study being conducted by the University of California to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Completed study which compared the effectiveness of silver nitrate drops, erythromycin ointment, or no medication in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye infections. Additionally study compared side effects of the two prophylactic agents.

Study sponsored by Assistance Publique-Hopitaux de Paris investigating Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone

NICHD program focuses on developing research that links PCCR medicine and science to the epidemiology, prevention, and treatment of childhood disabilities. The effort sponsors competitive research on all aspects of PCCR-including critical analyses of outcomes for children who are survivors of trauma, congenital anomalies, neonatal asphyxia, infectious processes, septic shock, and many other less common, but still devastating hildhood processes. The PCCR program also provides support for the Pediatric Critical Care Scientist Development Program (PCCSDP) , a national faculty training and career development program that develops successful pediatric critical care physician scientists conducting research to enhance the scientific understanding, clinical management, and rehabilitation of pediatric critical illness.

"For over 60 years the most appropriate oxygen level for preterm babies remains unknown. To answer this, we will combine data from over 5300 babies to be sure the expected benefits of lower oxygen for babies' eyes and lungs does not come at the expense of increasing death or major disability in these children. Planning to do this before the results of any of the trials are known is called a prospective meta-analysis. This is the first time this technique has been used in neonatal medicine.

Study is to determine if a weekly dose of 17P (Progesterone) given to women with preterm rupture of the membranes will: increase the probability of continuing the pregnancy until a favorable gestational age.Increase the interval between randomization and delivery. Decrease neonatal morbidity.

New England Journal of Medicine abstract of study to evaluate the effects of induction of moderate hypothermia in infants who had perinatal asphyxia. Study concluded that Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571 [controlled-trials.com] .)

Information on completed study evaluating Efficacy of Occupational Therapy Intervention in the Neonatal Intensive Care Unit

Multicenter, randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary outcome measure is eclampsia, and the secondary outcome measures include blood pressure control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal parameters including adverse effects and complications.