View clinical trials related to Premature Birth.
Filter by:The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.
Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV). Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.
Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need invasive treatments for eye disease. This research trial will give young infants born prematurely n-3 fish oil treatment and look at how this changes factors in the blood that promote disease. Detailed blood studies comparing infants with and without ROP will be performed and the infants will be followed over time to assess their eye development.
Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined. The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases. After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%. A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies. The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective. To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. This transfusion may improve circulating volume at birth leading to a smoother postnatal transition and overall improved outcome for preterm infants. The average blood volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean deliveries. Several several short-term benefits have been described including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
Introduction: The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein synthesis, but also intervene in weight gain. Most newborns receive amino acids throw parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth weight when discharged, so the weight its below the 10th percentile, which rises the risk for presenting alterations in neurodevelopment. Objective: To compare a higher doses of parenteral amino acids vs. standard doses, expecting an increased weight gain in the high amino acid doses group, meanwhile following the renal function security profile Methods: A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to an experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs and with less than 32 weeks of gestational age that match all the inclusion criteria. Statics Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact test were applied to categorical variables, t-student test to continuous variables, and ANOVA in multiple groups.