View clinical trials related to Premature Birth.
Filter by:There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care. Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics. One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion. In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.
To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.
There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of these are formulated using ingredients which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva, releasing the active ingredient(s) without the need for chewing or water, making them ideally suited to patients who find it difficult to swallow other oral dosage forms such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective alternative for oral administration of phosphate supplements to neonatal infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this treatment will be equal to standard therapy using an oral solution. Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate as soon as they have been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take place in the intensive care and special care baby units at the Princess Royal Maternity in Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from routine sampling only) to evaluate treatment effect. Babies will be randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment will be equivalent to standard oral solution.
The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant. Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.
Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and excitotoxicity are all known pathogenic mechanisms that mediate this injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries. During the past decade, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity, in general, rhEpo has been considered to be safe and well tolerated in preterm infants. EPO was considered not capable of passing through blood-brain-barrier at low dose. Evidence from animal experiments reveals that rhEpo must be given in high doses at the beginning or within a short (up to 6 hours), critical time period after the onset of brain injury to achieve a significant neuroprotective effect. A recent study using high-dose rhEpo (3000 U rhEpo/kg body weight at birth) for neuroprotection in very preterm infants revealed that no signs of adverse effects of early high-dose rhEpo treatment in very preterm infants were identified. Contrary to this, a recent study in PVL of a rat model revealed that using a low dose rhEpo (50-100 U/kg) was effective in the treatment of brain damage induced by hypoxia-ischemia and did not affect normal oligodendrocyte maturity. On this basis, the researchers intent to investigate (1) whether low-dose rhEpo (100 U/kg) or high-dose rhEpo (3,000 U/kg) given to very preterm infants (gestation age < 32 weeks) immediately after birth and subsequently during the first 2 days is safe and possesses neuroprotective properties;(2) whether there are gender differences in response to the hypoxia-ischemic insult and EPO treatment; (3)the pharmacokinetics of low dose and high dose rhEPO. Very preterm infants with gestational age of < 32 weeks and admitted to the NICU are eligible for enrollment.
Very low birth weight infants has increased dramatically their survival. Survival without neurologic disturbance varies a lot between centers.There is evidence that fluctuations in cerebral blood flow influences the appearance of intraventricular hemorrhage and itself implies a detrimental neurologic developing.The electroencephalography is the result of electric base membrane activity on rest, and it's influenced by the blood flow either. The Amplitude-integrated electroencephalography is a novel tool, that is capable to be continuously used at the patient bed and is easily to be read by the trained clinician.The hypothesis is that common procedures as Surfactant instilation, Indomethacin and Aminophyline infusion as the appearance of apneas alters the aEEG register. It is a prospective study that tries to recruit 10 < 30 weeks of gestational age with aprofen consent to monitorize the aEEG since birth to the seventh day of live.
Escitalopram has been claimed to have the highest selectivity for the human serotonin transporter relative to the noradrenaline or dopamine transporters. This might be associated with greater clinical efficacy. Most adverse events reported by escitalopram-treated patients are mild and transient. In this study, we compare escitalopram with placebo in the treatment of PE.
The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping. Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.