Background: The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants' lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy.
View Article and Find Full Text PDFThis case report describes a girl who presented antenatal arthrogryposis and postnatal hypotonia, generalized and respiratory weakness, joint deformities particularly affecting the lower limbs and poor swallow. By 5 months, cataracts, abnormal electroretinograms, visual evoked potentials (VEPs) and global developmental impairments were recognized. No causative variants were identified on targeted gene panels.
View Article and Find Full Text PDFTo evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019. This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated.
View Article and Find Full Text PDFIn the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required <10 days of intubation. However, in infants requiring intubation for ≥10 days, prolonged PDA exposure (≥11 days) was associated with an increased risk of moderate/severe BPD.
View Article and Find Full Text PDFBackground: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.
Methods/design: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial.
Trials
December 2019
Background: Infants born extremely preterm are at high risk of dying or suffering from severe brain injuries. Treatment guided by monitoring of cerebral oxygenation may reduce the risk of death and neurologic complications. The SafeBoosC III trial evaluates the effects of treatment guided by cerebral oxygenation monitoring versus treatment as usual.
View Article and Find Full Text PDFThe PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <28 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6.
View Article and Find Full Text PDFObjective: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks.
Methods: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.
Objective: To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given.
Study Design: A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.
Objective: Describe the course and outcomes in a UK national cohort of neonates with vein of Galen malformation identified before 28 days of life.
Methods: Neonates with angiographically confirmed vein of Galen malformation presenting to 1 of 2 UK treatment centers (2006-2016) were included; those surviving were invited to participate in neurocognitive assessment. Results in each domain were dichotomized into "good" and "poor" categories.
Arch Dis Child Fetal Neonatal Ed
September 2014
Optimal management of the patent ductus arteriosus (PDA) in the premature infant remains controversial. Despite considerable historical and physiological data indicating that a persistent PDA may be harmful, robust evidence of long-term benefits or harms from treatment is lacking. This has been equated to a lack of benefit but is also a reflection of the fact that most clinical trials were designed to assess the effects of short-term (2-8 days) rather than prolonged exposure to a PDA.
View Article and Find Full Text PDFAims: To examine the relationship between early duct diameter and patent ductus arteriosus (PDA) symptoms.
Methods: A retrospective study of infants <29 weeks of gestation with early colour Doppler assessment of PDA diameter, in whom PDA was managed conservatively, without cyclo-oxygenase inhibitor (COI) treatment.
Results: Gestation and birthweight, [median (range)], were 26 (23-28) weeks and 865 (500-1440) g, respectively.
Arch Dis Child Fetal Neonatal Ed
September 2012
Objective: Vein of Galen malformation (VGAM) in neonates presents a complex management challenge. Measurement of superior vena cava (SVC) blood flow may provide insights into the haemodynamics of VGAM and the effects of therapeutic intervention.
Methods: SVC flow was assessed in 15 neonates with VGAM.
Arch Dis Child Fetal Neonatal Ed
January 2012
Objective: To determine morbidity, mortality and associated risk factors following patent ductus arteriosus (PDA) ligation in premature infants.
Methods: Retrospective case note audit of premature infants referred to a national paediatric cardiothoracic surgical service (2001-2007) with univariate and multivariate analysis of potential risk factors for mortality and morbidity.
Results: 125 infants were enrolled (median gestational age 26 weeks (IQR 25-27 weeks), median birth weight 840 g (IQR 730-1035 g)).