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15 papers 0 to 25 followers Clinical trials in neonates
By Lauren Kelly Pediatric clinical pharmacologist
Hendrée E Jones, Andrea Fielder
BACKGROUND: Neonatal abstinence syndrome (NAS) occurs following prenatal opioid exposure. It is characterized by signs and symptoms indicating central nervous system hyperirritability and autonomic nervous system, gastrointestinal tract, and respiratory system dysfunction. OBJECTIVE: This article: (1) briefly reviews NAS history, including initial identification, assessment, and treatment efforts; (2) summarizes the current status of and current issues surrounding recent NAS assessment and treatment, and (3) details future directions in NAS conceptualization, measurement, and treatment...
November 2015: Preventive Medicine
Amish Jain, Prakesh S Shah
Patent ductus arteriosus (PDA) poses a diagnostic and therapeutic dilemma for clinicians. Diagnosis of persistent PDA and determination of its clinical and hemodynamic significance are challenging. Although the condition has been associated with substantial neonatal morbidities such as intraventricular hemorrhage, bronchopulmonary dysplasia, and necrotizing enterocolitis, most therapeutic approaches have failed to show improvement in these outcomes. As such, clinicians have tended toward conservative management strategies; however, the benefits and risks of such an approach are unclear...
September 2015: JAMA Pediatrics
Nils Chaillet, Alexandre Dumont, Michal Abrahamowicz, Jean-Charles Pasquier, Francois Audibert, Patricia Monnier, Haim A Abenhaim, Eric Dubé, Marylène Dugas, Rebecca Burne, William D Fraser
BACKGROUND: In Canada, cesarean delivery rates have increased substantially over the past decade. Effective, safe strategies are needed to reduce these rates. METHODS: We conducted a cluster-randomized, controlled trial of a multifaceted 1.5-year intervention at 32 hospitals in Quebec. The intervention involved audits of indications for cesarean delivery, provision of feedback to health professionals, and implementation of best practices. The primary outcome was the cesarean delivery rate in the 1-year postintervention period...
April 30, 2015: New England Journal of Medicine
Seetha Shankaran, Abbot R Laptook, Athina Pappas, Scott A McDonald, Abhik Das, Jon E Tyson, Brenda B Poindexter, Kurt Schibler, Edward F Bell, Roy J Heyne, Claudia Pedroza, Rebecca Bara, Krisa P Van Meurs, Cathy Grisby, Carolyn M Petrie Huitema, Meena Garg, Richard A Ehrenkranz, Edward G Shepherd, Lina F Chalak, Shannon E G Hamrick, Amir M Khan, Anne Marie Reynolds, Matthew M Laughon, William E Truog, Kevin C Dysart, Waldemar A Carlo, Michele C Walsh, Kristi L Watterberg, Rosemary D Higgins
IMPORTANCE: Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models. OBJECTIVE: To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy. DESIGN, SETTING, AND PARTICIPANTS: A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013...
December 24, 2014: JAMA: the Journal of the American Medical Association
Namasivayam Ambalavanan, Waldemar A Carlo, Lisa A Wrage, Abhik Das, Matthew Laughon, C Michael Cotten, Kathleen A Kennedy, Abbot R Laptook, Seetha Shankaran, Michele C Walsh, Rosemary D Higgins
OBJECTIVE: To determine the association of arterial partial pressure of carbon dioxide PaCO2 with severe intraventricular haemorrhage (sIVH), bronchopulmonary dysplasia (BPD), and neurodevelopmental impairment (NDI) at 18-22 months in premature infants. DESIGN: Secondary exploratory data analysis of Surfactant, Positive Pressure, and Oxygenation Randomised Trial (SUPPORT). SETTING: Multiple referral neonatal intensive care units. PATIENTS: 1316 infants 24 0/7 to 27 6/7 weeks gestation randomised to different oxygenation (SpO2 target 85-89% vs 91-95%) and ventilation strategies...
March 2015: Archives of Disease in Childhood. Fetal and Neonatal Edition
Lex W Doyle, Barbara Schmidt, Peter J Anderson, Peter G Davis, Diane Moddemann, Ruth E Grunau, Karel O'Brien, Koravangattu Sankaran, Eric Herlenius, Robin Roberts
OBJECTIVE: To determine the effect of neonatal caffeine treatment on rates of developmental coordination disorder (DCD). STUDY DESIGN: Children in the Caffeine for Apnea of Prematurity trial were assessed for motor performance (Movement Assessment Battery for Children [MABC]), clinical signs of cerebral palsy, and Full-Scale IQ at 5 years of age by staff who were unaware of the children's treatment group. DCD was defined as MABC<5th percentile in children with a Full-Scale IQ>69 who did not have a diagnosis of cerebral palsy...
August 2014: Journal of Pediatrics
Sanja Zivanovic, Janet Peacock, Mireia Alcazar-Paris, Jessica W Lo, Alan Lunt, Neil Marlow, Sandy Calvert, Anne Greenough
BACKGROUND: Results from an observational study involving neonates suggested that high-frequency oscillatory ventilation (HFOV), as compared with conventional ventilation, was associated with superior small-airway function at follow-up. Data from randomized trials are needed to confirm this finding. METHODS: We studied 319 adolescents who had been born before 29 weeks of gestation and had been enrolled in a multicenter, randomized trial that compared HFOV with conventional ventilation immediately after birth...
March 20, 2014: New England Journal of Medicine
Inger Bocca-Tjeertes, Arend Bos, Jorien Kerstjens, Andrea de Winter, Sijmen Reijneveld
OBJECTIVE: To determine how symmetric (proportionate; SGR) and asymmetric (disproportionate; AGR) growth restriction influence growth and development in preterms from birth to 4 years. METHODS: This community-based cohort study of 810 children comprised 86 SGR, 61 AGR, and 663 non-growth restricted (NGR) preterms, born in 2002 and 2003. Symmetrical growth restriction was defined as a birth weight below the 16th percentile (-1 SD) compared with full-terms and a head circumference (HC) z score not exceeding the infant's birth weight z score by >1 SD...
March 2014: Pediatrics
Deborah L Harris, Philip J Weston, Matthew Signal, J Geoffrey Chase, Jane E Harding
BACKGROUND: Neonatal hypoglycaemia is common, and a preventable cause of brain damage. Dextrose gel is used to reverse hypoglycaemia in individuals with diabetes; however, little evidence exists for its use in babies. We aimed to assess whether treatment with dextrose gel was more effective than feeding alone for reversal of neonatal hypoglycaemia in at-risk babies. METHODS: We undertook a randomised, double-blind, placebo-controlled trial at a tertiary centre in New Zealand between Dec 1, 2008, and Nov 31, 2010...
December 21, 2013: Lancet
Haresh Kirpalani, David Millar, Brigitte Lemyre, Bradley A Yoder, Aaron Chiu, Robin S Roberts
BACKGROUND: To reduce the risk of bronchopulmonary dysplasia in extremely-low-birth-weight infants, clinicians attempt to minimize the use of endotracheal intubation by the early introduction of less invasive forms of positive airway pressure. METHODS: We randomly assigned 1009 infants with a birth weight of less than 1000 g and a gestational age of less than 30 weeks to one of two forms of noninvasive respiratory support--nasal intermittent positive-pressure ventilation (IPPV) or nasal continuous positive airway pressure (CPAP)--at the time of the first use of noninvasive respiratory support during the first 28 days of life...
August 15, 2013: New England Journal of Medicine
Ben J Stenson, William O Tarnow-Mordi, Brian A Darlow, John Simes, Edmund Juszczak, Lisa Askie, Malcolm Battin, Ursula Bowler, Roland Broadbent, Pamela Cairns, Peter Graham Davis, Sanjeev Deshpande, Mark Donoghoe, Lex Doyle, Brian W Fleck, Alpana Ghadge, Wendy Hague, Henry L Halliday, Michael Hewson, Andrew King, Adrienne Kirby, Neil Marlow, Michael Meyer, Colin Morley, Karen Simmer, Win Tin, Stephen P Wardle, Peter Brocklehurst
BACKGROUND: The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used. METHODS: In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation...
May 30, 2013: New England Journal of Medicine
Seetha Shankaran, Athina Pappas, Scott A McDonald, Betty R Vohr, Susan R Hintz, Kimberly Yolton, Kathryn E Gustafson, Theresa M Leach, Charles Green, Rebecca Bara, Carolyn M Petrie Huitema, Richard A Ehrenkranz, Jon E Tyson, Abhik Das, Jane Hammond, Myriam Peralta-Carcelen, Patricia W Evans, Roy J Heyne, Deanne E Wilson-Costello, Yvonne E Vaucher, Charles R Bauer, Anna M Dusick, Ira Adams-Chapman, Ricki F Goldstein, Ronnie Guillet, Lu-Ann Papile, Rosemary D Higgins
BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33...
May 31, 2012: New England Journal of Medicine
Alison Leaf, Jon Dorling, Stephen Kempley, Kenny McCormick, Paul Mannix, Louise Linsell, Edmund Juszczak, Peter Brocklehurst
BACKGROUND: Growth-restricted preterm infants are at increased risk of developing necrotizing enterocolitis (NEC) and initiation of enteral feeding is frequently delayed. There is no evidence that this delay is beneficial and it might further compromise nutrition and growth. METHODS: Infants with gestation below 35 weeks, birth weight below the 10th centile, and abnormal antenatal umbilical artery Doppler waveforms were randomly allocated to commence enteral feeds "early," on day 2 after birth, or "late," on day 6...
May 2012: Pediatrics
Barbara Schmidt, Peter J Anderson, Lex W Doyle, Deborah Dewey, Ruth E Grunau, Elizabeth V Asztalos, Peter G Davis, Win Tin, Diane Moddemann, Alfonso Solimano, Arne Ohlsson, Keith J Barrington, Robin S Roberts
CONTEXT: Very preterm infants are prone to apnea and have an increased risk of death or disability. Caffeine therapy for apnea of prematurity reduces the rates of cerebral palsy and cognitive delay at 18 months of age. OBJECTIVE: To determine whether neonatal caffeine therapy has lasting benefits or newly apparent risks at early school age. DESIGN, SETTING, AND PARTICIPANTS: Five-year follow-up from 2005 to 2011 in 31 of 35 academic hospitals in Canada, Australia, Europe, and Israel, where 1932 of 2006 participants (96...
January 18, 2012: JAMA: the Journal of the American Medical Association
Yacov Rabi, Nalini Singhal, Alberto Nettel-Aguirre
OBJECTIVE: We conducted a blinded, prospective, randomized control trial to determine which oxygen-titration strategy was most effective at achieving and maintaining oxygen saturations of 85% to 92% during delivery-room resuscitation. METHODS: Infants born at 32 weeks' gestation or less were resuscitated either with a static concentration of 100% oxygen (high-oxygen group) or using an oxygen-titration strategy starting from a concentration of 100% (moderate-oxygen group), or 21% oxygen (low-oxygen group)...
August 2011: Pediatrics
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