View clinical trials related to Complication of Prematurity.
Filter by:Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone. The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).
There are several intervention programs involving multisensory and motor stimulations such as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a continuous program of early intervention involving very preterm infants' families in their first 12 months of life taking the chance of their neuronal plasticity during this period. Preterm infants born in our institution will be included when they complete 48 hours after birth (first intervention). All preterm infants and their mothers will be followed during neonatal period and pre hospital discharge they will have a second intervention ( to measure parental bond ). After discharge they will be conducted to follow up program and we will divided all very low birth weight infants included in the study in two groups according previous randomization: 1. Standard care with motor, and cognition evaluation and intervention according to their needs 2. Program of early intervention with parents' orientation independently of f the standard evaluation and care that will be performed. All phases of neurodevelopment will be evaluated, and the parents will be oriented to stimulate motor, language and cognition iteratively and continuously at home; this is a innovative method to improve very preterm neurodevelopment outcome. Randomization: in neonatal period, preterm infants will be sequentially randomized when they completed 48 hours after birth in: Group 1- conventional group (CG): standard care, according to the routine care of the NICU (skin-to skin care by mother, kangaroo care ). Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants. Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine care of the neonatal intensive care unit (NICU).
The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700 million in the US alone. In an effort to help mature the neonatal immune system, several adjuvant therapies have been studied; however, none have been implemented in clinical practice. One of the most frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a viable approach to reducing the incidence of early and late sepsis. This research study will characterize immune genomic expression and functional capacity at the time of birth in both term and preterm neonates and determine what effects, if any, that adjuvants have on this function. Additionally, this study will seek to determine if immune function correlates with certain microbiota.
This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.
Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied. This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.
Preterm children are at increased risk for autism spectrum disorders, with an estimated rate of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore, individuals with ASD who were born prematurely form a substantial body of children diagnosed with ASD. Premature birth confers an insult to the newborn at a neurologically vulnerable stage. Prematurity associated changes in oxygen tension can be detrimental to developing organs, the brain being one of the most rapidly developing organs in the second half of the pregnancy. Changes in oxygen tension mediate activation of proteins that change the course of cell development. In this study, we plan to measure changes in the expression of 3 proteins that may be affected by changes in oxygen level at birth. We will study the interaction between the proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2 years of age. The proteins are: 1. VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new blood vessels during embryonic development. 2. Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of different genes, many with developmentally critical functions. 3. CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that regulates migration of cells to their target destination during embryonic life. CXCR4 is expressed in areas of the brain and on cells that are known to be associated with ASD. We hypothesis that changes in oxygen tension in premature babies initiates a cascade of events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads to abnormal neurodevelopment. The investigators' primary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The investigators' secondary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay. Methods: 1. Premature babies will be recruited in the first day post delivery. 2. Blood samples will be collected at 3 time points during their hospitalization, and the expression of HIF-1, CXCR4 and VEGF will be determined. 3. Infants will undergo a complete developmental evaluation at 18-24 months of age . 4. Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the developmental evaluation.
The PEPI study is designed to provide a patterned feeding experience. By using a regularly occurring and necessary caregiving event, feeding, as the vehicle for the patterned experience, the intervention should be effective at promoting and reinforcing neuronal growth and connections that are critical for neurobehavioral and cognitive function while at the same time being cost effective in its delivery.
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarnitine esters across the inner mitochondrial membrane for Beta-oxidation and energy production. Intracellular carnitine deficiency induces an impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes from the diet and 25% from endogenous liver synthesis. In the neonatal period, more specifically in the premature, liver synthesis capacity is reduced because of immaturity of the biosynthetic pathway, and carnitine levels are related to exogenous sources. Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine levels fall during the first weeks of life, particularly in subjects requiring a prolonged exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has not been clearly demonstrated in these infants. However, most patients with primary carnitine deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency, commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter patients, carnitine supplementation improves all the symptoms. Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be one of the factors involved in the liver disease frequently associated with prolonged parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and functions. Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature neonates for liver, heart and muscle metabolism and functions. Study Type: Multicentric prospective and randomised study Subjects: Premature and very low birth weight neonates, defined by gestational age minor or equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be enrolled during 2.5 years Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d), from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo comparator): parenteral supplementation with an equivalent volume of sterile water.