Active clinical trials for "Premature Birth"

Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.

Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.

Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. The main objective of this population-based study, ie in intra uterine growth restricted preterm babies born before 30 weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.

The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?

The proposed research has the potential of contributing to the limited empirical literature on the relationship between maternal sensitivity and motor development of preterm infants. If indeed maternal attuned behaviors will be found to be associated with the quality of motor development, such a finding will support the effectiveness of physical therapy in guiding caregivers to attune their holding and touch of preterm infants. We hypothesize that mothers and infants' attunement during observed interaction will be related to the quality of preterm infants' spontaneous movements in the following ways: First, better maternal attunement to the infants needs, and in particular attunement of holding and touch will be associated with better quality of spontaneous movements of the infants. Second, more initiations and/or involvement of infants in interaction will be associated with better maternal attunement to the infant. Third, more initiations and/or involvement of infants in interaction will be associated with better quality of spontaneous movements and better achievements in developmental milestone. All hypotheses will be examined while controlling for maternal use of SSC method during hospitalization after birth and family demographic backgrounds.

The purpose of this study is to determine whether iron-fortified TPN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Generally the smaller Birth weight and gestational age the higher anemia rate in infants. About 25% to 85% of preterm infants develop evidence of anemia during infancy，77% VLBW（very low birth weight） infants developed anemia during the hospital stay. The effects of iron deficiency are pervasive and involve multiple organ systems. Poor physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and temperature instability has been attributed to iron deficiency in very low birth weight infants. So it is important to provide iron for preterm infants. As enteral nutrition is not feasible soon after birth in most preterm infants, Parenteral iron administration is an efficacious method for us to select. For most preterm infants the use of TPN(total parenteral nutrition) is very common during the first ten days of life, so we hypothesis that iron-fortified TPN may have a preventative and treatment effect on preterm infants using TPN as a supplementation of oral nutrition; Iron-fortified TPN(total parenteral nutrition) can also improve iron store status of preterm infants. The higher concentration of iron used in this study the larger preventative or treatment effect on preterm infants anemia; It is safe to add Small dose of iron agent to TPN.

Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants. Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered. The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.

This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(NICU).

Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity. This study is designed to evaluate the long-term developmental effects of one promising neuroprotective treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether this is an effective treatment to prevent brain injury associated with prematurity, and to lay the groundwork for further studies to improve the developmental outcome of infants delivered prematurely.

The primary objective of this multi-center clinical study is to evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an ophthalmologist experienced in ROP. We shall: Calculate the accuracy, using sensitivity and specificity, of the system to provide remote evaluations when compared with the findings of a "gold standard" indirect ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously trained in ROP diagnostic examinations (validity); Determine intra-reader and inter-reader agreement for deciding whether digital images indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by an ophthalmologist experienced in ROP (reliability); Determine whether imaging evaluation can be achieved for each baby (feasibility); Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety); Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness).