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Start Over Author "Paolo Tagliabue" Journal bmc pediatrics
2 results on '"Paolo Tagliabue"'

1. Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial

Author

Luca Filippi, Giacomo Cavallaro, Elettra Berti, Letizia Padrini, Gabriella Araimo, Giulia Regiroli, Valentina Bozzetti, Chiara De Angelis, Paolo Tagliabue, Barbara Tomasini, Giuseppe Buonocore, Massimo Agosti, Angela Bossi, Gaetano Chirico, Salvatore Aversa, Roberta Pasqualetti, Pina Fortunato, Silvia Osnaghi, Barbara Cavallotti, Maurizio Vanni, Giulia Borsari, Simone Donati, Giuseppe Nascimbeni, Giancarlo la Marca, Giulia Forni, Silvano Milani, Ivan Cortinovis, Paola Bagnoli, Massimo Dal Monte, Anna Maria Calvani, Alessandra Pugi, Eduardo Villamor, Gianpaolo Donzelli, and Fabio Mosca

Subjects
Propranolol, Beta blocker, Proliferative retinopathy, Angiogenesis, Pediatrics, RJ1-570
Abstract

Abstract Background Retinopathy of prematurity (ROP) still represents one of the leading causes of visual impairment in childhood. Systemic propranolol has proven to be effective in reducing ROP progression in preterm newborns, although safety was not sufficiently guaranteed. On the contrary, topical treatment with propranolol eye micro-drops at a concentration of 0.1% had an optimal safety profile in preterm newborns with ROP, but was not sufficiently effective in reducing the disease progression if administered at an advanced stage (during stage 2). The aim of the present protocol is to evaluate the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns at a more precocious stage of ROP (stage 1). Methods A multicenter, open-label, phase II, clinical trial, planned according to the Simon optimal two-stage design, will be performed to analyze the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns with stage 1 ROP. Preterm newborns with a gestational age of 23–32 weeks, with a stage 1 ROP will receive propranolol 0.2% eye micro-drops treatment until retinal vascularization has been completed, but for no longer than 90 days. Hemodynamic and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions, as well as electrocardiogram and echocardiogram, will be periodically performed to investigate treatment safety. Additionally, propranolol plasma levels will be measured at the steady state, on the 10th day of treatment. To assess the efficacy of topical treatment, the ROP progression from stage 1 ROP to stage 2 or 3 with plus will be evaluated by serial ophthalmologic examinations. Discussion Propranolol eye micro-drops could represent an ideal strategy in counteracting ROP, because it is definitely safer than oral administration, inexpensive and an easily affordable treatment. Establishing the optimal dosage and treatment schedule is to date a crucial issue. Trial registration ClinicalTrials.gov Identifier NCT02504944, registered on July 19, 2015, updated July 12, 2016. EudraCT Number 2014–005472-29.

Published
2017
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2. Evaluation of splanchnic oximetry, Doppler flow velocimetry in the superior mesenteric artery and feeding tolerance in very low birth weight IUGR and non-IUGR infants receiving bolus versus continuous enteral nutrition

Author

Giuseppe Paterlini, Diego Gazzolo, Gerard H. A. Visser, Maria Grazia Valsecchi, Valentina Bozzetti, Valeria Meroni, Paolo Tagliabue, Paola DeLorenzo, and Frank van Bel

Subjects
medicine.medical_specialty, Infant, Premature, Diseases, Kaplan-Meier Estimate, Enteral administration, Minimal enteral feeding, Study Protocol, Bolus (medicine), Feeding tolerance, Clinical Protocols, Mesenteric Artery, Superior, medicine.artery, Intra-uterine growth restriction, medicine, Laser-Doppler Flowmetry, Humans, Infant, Very Low Birth Weight, Superior mesenteric artery, Pediatrics, Perinatology, and Child Health, Oximetry, Splanchnic Circulation, Intermittent nutrition, Cross-Over Studies, Fetal Growth Retardation, Spectroscopy, Near-Infrared, business.industry, Infant, Newborn, lcsh:RJ1-570, Gestational age, lcsh:Pediatrics, Blood flow, Parenteral nutrition, Crossover study, Infant Formula, Surgery, Low birth weight, Treatment Outcome, Bolus nutrition, Anesthesia, Pediatrics, Perinatology and Child Health, Linear Models, Mesenteric artery Doppler, medicine.symptom, business, Enteral nutrition, Infant, Premature, Near infrared spectroscopy
Abstract

Background IUGR infants are thought to have impaired gut function after birth, which may result in intestinal disturbances, ranging from temporary intolerance to the enteral feeding to full-blown NEC. In literature there is no consensus regarding the impact of enteral feeding on intestinal blood flow and hence regarding the best regimen and the best rate of delivering the enteral nutrition. Methods/design This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW infants. Inclusion criteria * Weight at birth ranging: 700–1501 grams * Gestational age up to 25 weeks and 6 days * Written informed consent from parents or guardians Exclusion criteria * Major congenital abnormality * Patients enrolled in other trials * Significant multi-organ failure prior to trial entry * Pre-existing cutaneous disease not allowing the placement of the NIRS’ probe In the first 24 hours of life, between the 48th and 72nd hours of life, and during Minimal Enteral Feeding, all infants’ intestinal perfusion will be evaluated with NIRS and a Doppler of the superior mesenteric artery will be executed. At the achievement of an enteral intake of 100 mL/Kg/day the patients (IUGR and NON IUGR separately) will be randomized in 2 groups: Group A (n=10) will receive a feed by bolus (in 10 minutes); then, after at least 3 hours, they will receive the same amount of formula administered in 3 hours. Group B (n=10) will receive a feed administered in 3 hours followed by a bolus administration of the same amount of formula (in 10 minutes) after at least 3 hours. On the randomization day intestinal and cerebral regional oximetry will be measured via NIRS. Intestinal and celebral oximetry will be measured before the feed and 30 minutes after the feed by bolus during the 3 hours nutrition the measurements will be performed before the feed, 30 minutes from the start of the nutrition and 30 minutes after the end of the gavage. An evaluation of blood flow velocity of the superior mesenteric artery will be performed meanwhile. The infants of the Group A will be fed with continuous nutrition until the achievement of full enteral feeding. The infants of the Group B will be fed by bolus until the achievement of full enteral feeding. Discussion Evaluations of intestinal oximetry and superior mesenteric artery blood flow after the feed may help in differentiating how the feeding regimen alters the splanchnic blood flow and oxygenation and if the changes induced by feeding are different in IUGR versus NON IUGR infants. Trial registration number NCT01341236

Published
2012

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