View clinical trials related to Infant, Premature.
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Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common. However, prolonged use of a respirator can itself cause long-term complications. Furthermore, commonly used drugs to improve the regularity of breathing may have long-term consequence only recently recognized. This study will compare two different types of assistance using a nasally applied breathing assist device. The aim is to see which type of assistance is best at avoiding the need for both prolonged respirator use and drugs to regulate breathing.
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine, and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures. These samples are being tested using the new methods and compared with standard culture results. Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age.
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD have been identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, we developed a quality improvement program. For this study, 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, we compared changes in the rate of survival without BPD at 36 weeks corrected age between the intervention and control sites.
The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.