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Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes. Study Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL/kg/day for one day) or the control group, receiving extended trophic feeding (20 to 25 mL/kg/day for three days) prior to advancing enteral feeds until full feeding volume (140 mL/kg/day) is achieved. Eligibility Criteria Preterm infants with gestational ages between 25 0/7 and 31 6/7 weeks and a birthweight of \<1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \<5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital/genetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded. Study Intervention/Methods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable. Primary Outcome Late-onset sepsis, defined as positive blood, urine, and/or cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more. Secondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.
The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.
There is a paucity of data on the timing and role of enteral nutrition in septic shock. The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.
This study will examine the safety and effectiveness of an experimental drug called GDNF delivered through an investigational device to treat progressive supranuclear palsy (PSP). The drug will be administered directly into the brain through catheters attached to an infusion pump implanted in the abdomen. The study will evaluate 1) if the drug is safe and well tolerated when given by this method; 2) the performance of the catheters and pump system, and 3) the effects of GDNF on PSP symptoms. PSP is a rare neurological disease that causes eye movement dysfunction, muscle rigidity, slowness of movement, swallowing, speech, emotional, cognitive and personality problems. Patients 35 to 75 years old with PSP may be eligible for this study. Candidates will be screened at the National Institutes of Health outpatient clinic in Bethesda, MD, with a medical history, physical examination, neurological and neuropsychiatric evaluations, blood tests, electrocardiogram, CT scan of the brain, and baseline studies including a special eye examination, evaluation of symptoms, lumbar puncture (spinal tap) and psychiatric interview. Patients enrolled in the study will undergo surgery to place two catheters into the brain and two infusion pumps under the skin in the upper abdomen. The surgery will be performed at Vanderbilt University Medical Center in Nashville, TN. It will be done under general anesthesia and will require a 3 day hospitalization. Within 24 hours after the surgery, a CT scan of the brain will be done to ensure the catheters are properly placed. Patients return to NIH two weeks after surgery for post-surgery examination and treatment initiation. All patients will receive continuous infusions of GNDF through one catheter and placebo (an inactive salt solution) through the other for 6 months. Half of the patients will receive placebo in the right side of the brain and GNDF in the left, and half will receive GNDF in the right side of the brain and placebo in the left. All patients will also undergo the following procedures: Brief physical examination, and evaluation of symptoms and adverse side effects - every 2 weeks Blood and urine tests - every 2 weeks for the first 2 months and then every 8 weeks until the end of the study CT scan to check catheter placement - weeks 9 and 27 Thorough evaluation of symptoms - before beginning treatment and weeks 1, 5, 9, 17 and 27 Neuropsychiatric evaluation - week 27 Special eye examination - weeks 1 and 27 Lumbar puncture - week 27 Additional blood tests to measure drug concentration and antibodies - 6 times during the study In addition, some patients may be asked to have positron emission tomography (PET) scans or a single photon emission tomography (SPECT) scan, or both. The potential benefit of GDNF is unknown. In studies with rats and monkeys, GNDF increased the number and size of brain cells containing the chemical messenger dopamine and some movement and balance problems were lessened. Earlier studies of GDNF infused into the ventricles of patients with Parkinson's disease showed no benefit and no serious harm.