Discovery Labs Receives $1.9 Million Fast Track SBIR Grant from the National Institutes of Health (NIH) to Support AEROSURF® Phase 2a Clinical Study
Warrington, PA, June 17, 2014 — Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced that it has been awarded the final $1.9 million of a $2.4 million Fast Track Small Business Innovation Research (SBIR) Grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). This award will provide support for the ongoing phase 2a clinical trial for AEROSURF®, Discovery Labs’ investigational combination drug/device product. AEROSURF is in development to provide KL4 surfactant therapy through nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS) in premature infants. Discovery Labs was notified in 2010 that it was eligible for consideration under this grant program, and previously received $580,000 to support development activities related to its capillary aerosol generator technology. The company expects to utilize the $1.9 million during 2014.
Preterm newborns '30-50% more likely to survive in busy neonatal centers'
In the UK, specialist neonatal units that treat a large volume of infants were found to have much greater survival rates than less busy units, a new study published in BMJ Open reports. Specifically, the research found that the chances of survival were 30% higher for babies born prematurely after 27-32 weeks of pregnancy, and 50% higher for babies born after less than 27 weeks of pregnancy.
Late Referral for About One in Four Neonates With Critical CHD
A considerable proportion of neonates with critical congenital heart disease (CCHD) are not referred to a cardiac center by age 4 days, according to a study published online June 30 in Pediatrics. David E. Fixler, M.D., from the University of Texas Southwestern Medical Center in Dallas, and colleagues describe the correlation between timing of referral to a cardiac center and mortality in 2,360 neonates with CCHD, born before pulse oximetry screening (1996 to 2007).
Cesarean section may cause epigenetic changes
A new study from Karolinska Institute indicates that the mode of delivery could make an imprint in the stem cells of the newborn infant. The finding may be of interest for understanding why individuals born by cesarean section statistically have an increased risk of immunological diseases. However, it is still unclear if this so-called epigenetic mechanism is temporary or remains over time.
Deaths of four premature babies and burns in dozens more linked to antiseptic, says regulator
The deaths of four premature babies and serious burns in dozens more have been linked to an antiseptic solution, the medicines regulator has warned, urging doctors to use it sparingly. Doctors use chlorhexidine solution to clean the skin of premature babies before tubes are inserted for feeding and medicines but it has been found to cause serious chemical burns when used carelessly.
The preemie brain moves in its own way
Movement impairments can be among the most disabling of all problems that affect people born prematurely. Up to one third of all children born very preterm have noticeable movement problems. These problems range from simple clumsiness to more disabling conditions such as cerebral palsy. It has recently been suggested that movement problems may cause preemies to do worse on academic and cognitive tests.
Study proves telemedicine's value in preemie eye exams
A new study has determined that telemedicine can be used successfully to identify newborn infants who need specialized medical treatment for retinopathy or prematurity (ROP), a leading cause of treatable blindness. The study, conducted at 13 neonatal intensive care units in the United States and Canada and recently published in JAMA Ophthalmology, found that trained non-physician evaluators at a remote reading center could identify newborns at risk of acquiring ROP by studying retinal images transmitted to their computer screens.
Prepregnancy Obesity Linked to Earliest Preterm Births
Obese women who become pregnant are more likely to deliver before 28 weeks of pregnancy?, but the association between prepregnancy body mass index (BMI) and risk for preterm birth is complex and affected by race/ethnicity, gestational age, and parity, according to findings of a population-based cohort study published in the July issue of Paediatric and Perinatal Epidemiology.
Heart rate variability may predict risk of disease in premature infants
Measuring variability of heart rate may identify premature infants at risk of developing necrotizing enterocolitis, a serious inflammatory condition that can lead to death, according to Penn State College of Medicine researchers. Necrotizing enterocolitis, or NEC, may lead to destruction of the intestinal wall and vital organ failure. It affects 6 to 10 percent of premature infants within the first two weeks of life.
Preterm infants have higher risk for RSV
Preterm infants who did not receive respiratory syncytial virus prophylaxis were three times more likely to be hospitalized for RSV than infants of the general population. Additional risk factors for RSV infection included daycare attendance or having siblings who attended daycare, according to study findings in The Pediatric Infectious Disease Journal.
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Surgery may boost risks for smallest infants
Very-low-birth-weight (VLBW) babies who undergo major surgery appear to have an increased risk of death or subsequent neurodevelopmental impairment, according to a new study published June 16 in the journal JAMA Pediatrics. Major surgeries are procedures that require general anesthesia, and some animal studies have suggested that general anesthesia can increase the risk for neurocognitive or behavioral deficits.