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151. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial

Author

MS Neonatologie, Brain, Hyttel-Sorensen, Simon, Pellicer, Adelina, Alderliesten, Thomas, Austin, Topun, Van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel R., Fumagalli, Monica, Gluud, Christian, Grevstad, Berit, Hagmann, Cornelia, Lemmers, Petra, Van Oeveren, Wim, Pichler, Gerhard, Plomgaard, Anne Mette, Riera, Joan, Sanchez, Laura, Winkel, Per, Wolf, Martin, Greisen, Gorm, MS Neonatologie, Brain, Hyttel-Sorensen, Simon, Pellicer, Adelina, Alderliesten, Thomas, Austin, Topun, Van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel R., Fumagalli, Monica, Gluud, Christian, Grevstad, Berit, Hagmann, Cornelia, Lemmers, Petra, Van Oeveren, Wim, Pichler, Gerhard, Plomgaard, Anne Mette, Riera, Joan, Sanchez, Laura, Winkel, Per, Wolf, Martin, and Greisen, Gorm

Published
2015

152. Cerebral near infrared spectroscopy oximetry in extremely preterm infants:phase II randomised clinical trial

Author

Hyttel-Sorensen, Simon, Pellicer, Adelina, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel R, Fumagalli, Monica, Gluud, Christian, Grevstad, Berit, Hagmann, Cornelia, Lemmers, Petra, van Oeveren, Wim, Pichler, Gerhard, Plomgaard, Anne Mette, Riera, Joan, Sanchez, Laura, Winkel, Per, Wolf, Martin, Greisen, Gorm, Hyttel-Sorensen, Simon, Pellicer, Adelina, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel R, Fumagalli, Monica, Gluud, Christian, Grevstad, Berit, Hagmann, Cornelia, Lemmers, Petra, van Oeveren, Wim, Pichler, Gerhard, Plomgaard, Anne Mette, Riera, Joan, Sanchez, Laura, Winkel, Per, Wolf, Martin, and Greisen, Gorm

Abstract

OBJECTIVE: To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.DESIGN: Phase II randomised, single blinded, parallel clinical trial.SETTING: Eight tertiary neonatal intensive care units in eight European countries.PARTICIPANTS: 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.INTERVENTIONS: Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).MAIN OUTCOME MEASURES: The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography.RANDOMISATION: Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥ 26 weeks).BLINDING: Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.RESULTS: The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 5

Published
2015

153. Role of ultrasonography in the assessment of correct endotracheal tube placement in neonates.

Author

Descamps, Claire‐Sophie, Beissel, Anne, Vo Van, Philippe, Butin, Marine, Stacoffe, Nicolas, Giai, Joris, Claris, Olivier, Nguyen, Kim‐An, Descamps, Claire-Sophie, and Nguyen, Kim-An

Subjects
ENDOTRACHEAL tubes, ENDOTRACHEAL suctioning, NEWBORN infants, ULTRASONIC imaging, TRACHEA intubation
Abstract

The main purpose of this study was to evaluate bedside tUS, carried out by neonatologists to assess correct ETT placement, compared with XR. Secondary objectives were threefold: to determine tUS reproducibility between neonatologists, to compare time delays between tUS and XR, and to evaluate its tolerance. We analysed sensitivity of tUS to detect the same ETT position as XR and Kappa coefficient for the concordance between XR and tUS. [Extracted from the article]

Published
2020
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154. The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

Plomgaard, Anne M., primary, van Oeveren, Wim, additional, Petersen, Tue H., additional, Alderliesten, Thomas, additional, Austin, Topun, additional, van Bel, Frank, additional, Benders, Manon, additional, Claris, Olivier, additional, Dempsey, Eugene, additional, Franz, Axel, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Hagmann, Cornelia, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, Winkel, Per, additional, and Greisen, Gorm, additional

Published
2015
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155. The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings

Author

Riera, Joan, primary, Hyttel-Sorensen, Simon, additional, Bravo, María Carmen, additional, Cabañas, Fernando, additional, López-Ortego, Paloma, additional, Sanchez, Laura, additional, Ybarra, Marta, additional, Dempsey, Eugene, additional, Greisen, Gorm, additional, Austin, Topun, additional, Claris, Olivier, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Lemmers, Petra, additional, Pichler, Gerhard, additional, Plomgaard, Anne Mette, additional, van Bel, Frank, additional, Wolf, Martin, additional, and Pellicer, Adelina, additional

Published
2015
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156. Mélanges pour nutrition parentérale en néonatalogie : avantages et spécificités des préparations hospitalières

Author

Baudoin, A., Pirot, Fabrice, Duval, S., Prôvot, S., Diouf, E., Tall, Mamadou-Lamine, Claris, Olivier, Pivot, Christine, service pharmaceutique Hôpital Edouard Herriot, Hospices Civils de Lyon, Hospices Civils de Lyon (HCL)-Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Fonctions Normales et Pathologiques de la Barrière Cutanée [Hôpital Edouard Herriot - HCL], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service pharmaceutique Hôpital Clocheville, Centre Hospitalier Régional et Universitaire de Tours, Hôpital de Clocheville-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Service Réanimation Néonatale, Groupement Hospitalier Est, Hospices Civils de Lyon, Hospices Civils de Lyon (HCL)-Groupement Hospitalier Est, and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital de Clocheville

Subjects
[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences
Abstract

CONTEXTE La prise en charge des prématurés de faible poids (

Published
2013

157. Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study.

Author

Fischer Fumeaux, Céline J., Denis, Angélique, Prudon, Malika B., Plaisant, Frank, Essomo Megnier-Mbo, Christine Murielle, Fernandes, Laetitia, Touzet, Sandrine, Claris, Olivier, and Laborie, Sophie

Subjects
BREASTFEEDING, MOTHER-infant relationship, PERINATAL care
Abstract

Background: Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. Objectives: This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation. Methods: This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression. Results: More than one-third (36.2%) of breastfed neonates did not receive any MOM during their first week, mainly due to organisational constraints and staff reluctance. Maternal satisfaction related to early raw MOM use was high (96%), and was coupled with a more frequent maternal feeling of being supported in breastfeeding (p = 0.003). There was a significant association between early use of MOM and breastfeeding continuation at discharge (OR 2.92, 95% CI 1.94-4.40, p < 0.0001), which persisted 6 months later (OR 2.70, 95% CI 1.21-6.03, p = 0.023). This association appeared independent in multivariable analyses (at discharge: aOR 2.03, 95% CI 1.27-3.25, p = 0.003; 6 months later: aOR 2.46, 95% CI 1.02-5.92, p = 0.045). Conclusion: While the early use of raw MOM in hospitalised neonates can be limited by multiple factors, it appears supportive for mothers, and might represent a simple opportunity to improve breastfeeding in neonatal units. [ABSTRACT FROM AUTHOR]

Published
2018
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158. Management and outcome challenges in newborns with gastroschisis: A 6-year retrospective French study.

Author

Tosello, Barthelemy, Zahed, Meriem, Guimond, Floriane, Baumstarck, Karine, Faure, Alice, Michel, Fabrice, Claris, Olivier, Gire, Catherine, Berakdar, Isabelle, Massardier, Jerome, D'Ercole, Claude, and Merrot, Thierry

Subjects
GASTROSCHISIS, NEONATAL mortality, NEONATAL intensive care, PARENTERAL feeding, GESTATIONAL age, PREGNANCY complications, LOGISTIC regression analysis, PUBLIC health, THERAPEUTICS
Abstract

Objective: To identify the gestational age (GA) at which risk of mortality and severe outcome was minimized comparing preterm delivery and expectant management.Methods: Retrospective study performed between 2009 and 2014 of newborns with gastroschisis in three large French level III neonatal intensive care units. Each department followed two distinct strategies: elective delivery at 35 weeks' GA and a delayed approach.Results: We included 69 gastroschisis cases. The lengths of stay lasting more than 60 days were significantly greater in the planned delivery group than in the expectant approach group (18/30 (60%) vs. 8/39 (20.5%), p = 0.001). Gastroschisis cases receiving antenatal corticoids during the last two weeks of gestation required significantly less surgeries during their initial stay (p = 0.003) as well as shorter parenteral feedings (p = 0.002). A multivariate logistic regression showed that a GA of less than 36 weeks' GA was is a pejorative factor for a stay above 60 days, regardless of whether it was a simple or complex gastroschisis, (OR= 3.8; p = 0.021). A complex gastroschisis was a risk factor for significantly longer parenteral feedings, regardless of the center where patient is treated (Beta = -0.3, p = 0.035).Conclusions: Future research should focus on decisions about delivery timing by incorporating risk of neonatal morbidity. [ABSTRACT FROM AUTHOR]

Published
2017
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159. Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

Author

Plomgaard, Anne M, primary, Hagmann, Cornelia, additional, Alderliesten, Thomas, additional, Austin, Topun, additional, van Bel, Frank, additional, Claris, Olivier, additional, Dempsey, Eugene, additional, Franz, Axel, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Greisen, Gorm, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, and Benders, Manon, additional

Published
2015
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161. Neurodevelopment and Health-Related Quality of Life in Infants Born with Gastroschisis: A 6-Year Retrospective French Study.

Author

Tosello, Barthelemy, Zahed, Meriem, Guimond, Floriane, Baumstarck, Karine, Faure, Alice, Michel, Fabrice, Claris, Olivier, Massardier, Jerome, Gire, Catherine, and Merrot, Thierry

Subjects
QUALITY of life, GASTROSCHISIS, INFANT diseases, INTENSIVE care units, PARENTS, CHILD development, COMPARATIVE studies, HEALTH surveys, RESEARCH methodology, MEDICAL cooperation, PROGNOSIS, QUESTIONNAIRES, RESEARCH, EVALUATION research, CROSS-sectional method, RETROSPECTIVE studies, DISEASE complications, DIAGNOSIS, THERAPEUTICS
Abstract

Introduction Quantify quality of life (QoL) outcomes in gastroschisis children is little assessed. The primary objective was to describe the long-term outcome of newborns with gastroschisis treated in three tertiary care hospitals of France in terms of neurodevelopment and QoL. Materials and Methods The study reported was a cross-sectional, descriptive multicentric retrospective study assessing the outcome of newborns with gastroschisis, born between January 1, 2009, and December 31, 2014, treated at two large and French level III neonatal intensive care units. Long-term outcome data were assessed by questionnaires sent to the infants' parents. Questionnaires explored global health, neurological development, and quality of life (overall assessment including socio-economic and medical), Age & Stages Questionnaire, infants' quality of life (KIDSCREEN), and quality of parents' life (General Questionnaire Short Form-36). Results In this study, 50% of the survivor's families answered the assessment form (n = 33). The average follow-up age was 40 months, ranging from 8 months to 6 years. Cases of simple gastroschisis more often had a normal score for "communication" (p = 0.033), while patients who received morphine for a longer duration had significantly lower scores for the items "communication" and "problem resolving" (p = 0.024 and p = 0.011, respectively). Children's QoL was significantly lower for patients with gestational age younger than 36 weeks (p = 0.023) and for patients born following "fetal cause delivery" (p = 0.022). Parents had a significantly higher physical composite score if their child underwent primary closure (p = 0.012). Conclusion Our analyses confirm the idea that cases of complex gastroschisis and preterm delivery may lead to poorer outcome. Such hindsight (40 months in mean) allowed for an interesting assessment of development long after the patient's initial hospitalization and to confirm these results, a standardized neuropsychological evaluation of patients should be done when at least 6 years old. An accurate assessment of the social environment and its impact on the development and QoL of children will be fundamental to avoid selection bias. [ABSTRACT FROM AUTHOR]

Published
2017
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162. Policy of feeding very preterm infants with their mother's own fresh expressed milk was associated with a reduced risk of bronchopulmonary dysplasia.

Author

Dicky, Odile, Ehlinger, Virginie, Montjaux, Nathalie, Gremmo‐Féger, Gisèle, Sizun, Jacques, Rozé, Jean‐Christophe, Arnaud, Catherine, Casper, Charlotte, Ancel, Pierre‐Yves, Azcona, Barbara, Bedu, Antoine, Biran, Valérie, Boubred, Farid, Cambonie, Gilles, Chollat, Clément, Claris, Olivier, Desfrere, Luc, Gascoin, Géraldine, Hascoet, Jean‐Michel, and Lapillonne, Alexandre

Subjects
PREMATURE infant nutrition, BREAST milk, BRONCHOPULMONARY dysplasia, PUBLIC health, NEONATAL intensive care, FOOD pasteurization, LOW birth weight, DISEASE risk factors, ARTIFICIAL feeding, COMPARATIVE studies, PREMATURE infants, RESEARCH methodology, MEDICAL cooperation, QUESTIONNAIRES, RESEARCH, WEIGHT gain, EVALUATION research, HOSPITAL mortality
Abstract

Aim: Since 2005, the French Food Safety Agency has recommended that very preterm or low-birthweight babies should be fed with pasteurised, expressed breastmilk, and feeding policies on this vary widely in French neonatal units. We investigated the differences between using a mother's expressed milk, in fresh or pasteurised forms, for very preterm infants.Methods: This observational multicentre study analysed data on 926 very preterm infants: 636 from neonatal units who used the mother's own fresh milk and 290 who used the mother's milk after pasteurisation. We analysed necrotising enterocolitis, bronchopulmonary dysplasia, in-hospital mortality, late-onset sepsis, weight gain, length of hospital stay, the duration of parenteral nutrition and the duration of enteral feeding with a nasogastric tube. Multivariate analyses were conducted to assess the impact of maternal milk policies.Results: After adjustment, there was a reduced risk of bronchopulmonary dysplasia in the fresh milk group with an odds ratio of 0.40 and 95% confidence interval of 0.27-0.67 (p < 0.001). No other statistically significant differences were observed.Conclusion: Feeding very preterm infants with their mother's expressed fresh milk was associated with a reduced risk of bronchopulmonary dysplasia, and further investigations are needed to evaluate the clinical impact of this practice. [ABSTRACT FROM AUTHOR]

Published
2017
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163. Predictive value of maternal second-generation thyroid-binding inhibitory immunoglobulin assay for neonatal autoimmune hyperthyroidism

Author

Abeillon-du Payrat, Juliette, primary, Chikh, Karim, additional, Bossard, Nadine, additional, Bretones, Patricia, additional, Gaucherand, Pascal, additional, Claris, Olivier, additional, Charrié, Anne, additional, Raverot, Véronique, additional, Orgiazzi, Jacques, additional, Borson-Chazot, Françoise, additional, and Bournaud, Claire, additional

Published
2014
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164. Shielding Parenteral Nutrition Solutions From Light

Author

Laborie, Sophie, primary, Denis, Angélique, additional, Dassieu, Gilles, additional, Bedu, Antoine, additional, Tourneux, Pierre, additional, Pinquier, Didier, additional, Kermorvant, Elsa, additional, Millet, Véronique, additional, Klosowski, Serge, additional, Patural, Hugues, additional, Clamadieu, Catherine, additional, Brunhes, Anne, additional, Walther, Marie, additional, Jaisson-Hot, Isabelle, additional, Mandy, Bruno, additional, and Claris, Olivier, additional

Published
2014
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165. A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC) : study protocol for a randomized controlled trial

Author

Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Greisen, Gorm, Grevstad, Berit, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Lindschou, Jane, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Skoog, Maria, Winkel, Per, Wolf, Martin, Gluud, Christian, Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Greisen, Gorm, Grevstad, Berit, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Lindschou, Jane, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Skoog, Maria, Winkel, Per, Wolf, Martin, and Gluud, Christian

Abstract

Background: Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO(2). Methods/Design: SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO(2) values outside the target ranges of 55% to 85%, that is, the 'burden of hypoxia and hyperoxia' expressed in '%hours'. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age

Published
2013
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166. The SafeBoosC Phase II Randomised Clinical Trial : A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

Author

Pellicer, Adelina, Greisen, Gorm, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Hyttel-Sorensen, Simon, Lemmers, Petra, Naulaers, Gunnar, Pichler, Gerhard, Roll, Claudia, van Bel, Frank, van Oeveren, Wim, Skoog, Maria, Wolf, Martin, Austin, Topun, Pellicer, Adelina, Greisen, Gorm, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Hyttel-Sorensen, Simon, Lemmers, Petra, Naulaers, Gunnar, Pichler, Gerhard, Roll, Claudia, van Bel, Frank, van Oeveren, Wim, Skoog, Maria, Wolf, Martin, and Austin, Topun

Abstract

Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting.

Published
2013
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167. Clinical use of cerebral oximetry in extremely preterm infants is feasible

Author

Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene M., Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Stoy, Lina Saem, Wolf, Martin, Greisen, Gorm, Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene M., Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Stoy, Lina Saem, Wolf, Martin, and Greisen, Gorm

Abstract

INTRODUCTION: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO(2)) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO(2) was 64.2 +/- 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO(2) below 55% and four episodes with an rStO(2) above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO(2) which in 13 of the 18 times resulted in an out-of-range SpO(2). Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required.

Published
2013

168. The SafeBoosC Phase II Randomised Clinical Trial:A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

Author

Pellicer, Adelina, Greisen, Gorm, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagally, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Hyttel-Sorensen, Simon, Lemmers, Petra, Naulaers, Gunnar, Pichler, Gerhard, Roll, Claudia, van Bel, Frank, van Oeveren, Wim, Skoog, Maria, Wolf, Martin, Austin, Topun, Pellicer, Adelina, Greisen, Gorm, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagally, Monica, Gluud, Christian, Hagmann, Cornelia, Hellström-Westas, Lena, Hyttel-Sorensen, Simon, Lemmers, Petra, Naulaers, Gunnar, Pichler, Gerhard, Roll, Claudia, van Bel, Frank, van Oeveren, Wim, Skoog, Maria, Wolf, Martin, and Austin, Topun

Published
2013

169. A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC):study protocol for a randomized controlled trial

Author

Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Greisen, Gorm, Grevstad, Berit, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Lindschou, Jane, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Skoog, Maria, Winkel, Per, Wolf, Martin, Gluud, Christian, Hyttel-Sorensen, Simon, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Greisen, Gorm, Grevstad, Berit, Hagmann, Cornelia, Hellström-Westas, Lena, Lemmers, Petra, Lindschou, Jane, Naulaers, Gunnar, van Oeveren, Wim, Pellicer, Adelina, Pichler, Gerhard, Roll, Claudia, Skoog, Maria, Winkel, Per, Wolf, Martin, and Gluud, Christian

Published
2013

171. A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

Author

Hyttel-Sorensen, Simon, primary, Austin, Topun, additional, van Bel, Frank, additional, Benders, Manon, additional, Claris, Olivier, additional, Dempsey, Eugene, additional, Fumagalli, Monica, additional, Greisen, Gorm, additional, Grevstad, Berit, additional, Hagmann, Cornelia, additional, Hellstr�m-Westas, Lena, additional, Lemmers, Petra, additional, Lindschou, Jane, additional, Naulaers, Gunnar, additional, van Oeveren, Wim, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, Roll, Claudia, additional, Skoog, Maria, additional, Winkel, Per, additional, Wolf, Martin, additional, and Gluud, Christian, additional

Published
2013
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174. Methicillin-Resistant Staphylococcus capitis with Reduced Vancomycin Susceptibility Causes Late-Onset Sepsis in Intensive Care Neonates

Author

Rasigade, Jean-Philippe, primary, Raulin, Olivia, additional, Picaud, Jean-Charles, additional, Tellini, Charlotte, additional, Bes, Michele, additional, Grando, Jacqueline, additional, Ben Saïd, Mohamed, additional, Claris, Olivier, additional, Etienne, Jerome, additional, Tigaud, Sylvestre, additional, and Laurent, Frederic, additional

Published
2012
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175. The apparent breastfeeding paradox in very preterm infants: relationship between breast feeding, early weight gain and neurodevelopment based on results from two cohorts, EPIPAGE and LIFT

Author

Rozé, Jean-Christophe, primary, Darmaun, Dominique, additional, Boquien, Clair-Yves, additional, Flamant, Cyril, additional, Picaud, Jean-Charles, additional, Savagner, Christophe, additional, Claris, Olivier, additional, Lapillonne, Alexandre, additional, Mitanchez, Delphine, additional, Branger, Bernard, additional, Simeoni, Umberto, additional, Kaminski, Monique, additional, and Ancel, Pierre-Yves, additional

Published
2012
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176. Delivery room deaths of extremely preterm babies: an observational study

Author

Durrmeyer, Xavier, Scholer-Lascourrèges, Claire, Boujenah, Laurence, Bèétrèéémieux, Pierre, Claris, Olivier, Garel, Micheline, Kaminski, Monique, Foix-L'Helias, Laurence, and Caeymaex, Laurence

Abstract

ObjectiveMany extremely preterm neonates die in the delivery room (DR) after decisions to withhold or withdraw life-sustaining treatments or after failed resuscitation. Specific palliative care is then recommended but sparse data exist about the actual management of these dying babies. The objective of this study was to describe the clinical course and management of neonates born between 22 and 26 weeks of gestation who died in the DR in France.Design, setting, patientsProspective study including neonates, who were liveborn between 22+0and 26+6weeks of gestation and died in the DR in 2011, among infants included in the EPIPAGE-2 study at the 18 centres participating in this substudy of extremely preterm neonates. Data were collected by a questionnaire completed by the professional caring for each baby.ResultsThe study included 73 children, with a median (IQR) gestational age of 24 (23–24) weeks. Median (IQR) duration of life was 53 (20–82) min. All but one were both wrapped and warmed. Pain was assessed for 72%, although without using any scale. Gasping was described for 66%. Comfort medications were administered to 35 children (50%), significantly more frequently to babies with gasping (p=0.001). Mother–child contact was reported for 78%, and psychological support offered to parents of 92%.ConclusionsNon-pharmacological comfort care and parental support were routinely given. Comfort medication was given much more frequently than previously reported in other DRs. These data should encourage work on the indications for comfort medication and the interpretation of gasping.

Published
2017
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189. Unlicensed and off-label drug use: a prospective study in French NICU.

Author

Riou, Stéphanie, Plaisant, Frank, Maucort Boulch, Delphine, Kassai, Behrouz, Claris, Olivier, and Nguyen, Kim‐An

Subjects
DRUG prescribing, OFF-label use (Drugs), PERINATAL care, FERROUS fumarate, FOLINIC acid, ANTIBIOTICS
Abstract

The article focuses on a study conducted on medical prescription of unlicensed and off label drugs to neonates by pediatricians in Lyon, France. Topics discussed include the most prescribed drugs, data on the pharmacokinetics and tolerability of antibiotics in newborns and preterm infants, and effects of various unlicensed drugs including folinic acid, ferrous fumarate and phytomenadione.

Published
2015
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190. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical.

Author

Hyttel-Sorensen, Simon, Pellicer, Adelina, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel R., Fumagalli, Monica, Gluud, Christian, Grevstad, Berit, Hagmann, Cornelia, Lemmers, Petra, van Oeveren, Wim, Pichler, Gerhard, Plomgaard, Anne Mette, Riera, Joan, Sanchez, Laura, and Winkel, Per

Published
2015
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192. Le prématuré de moins de 28 semaines, sa réanimation et son avenir

Author

Salle, Bernard, primary, Sureau, Claude, additional, Sureau, MM. Claude, additional, Salle, Bernard, additional, Vert, Paul, additional, Le Foyer de Costil, Mmes Huguette, additional, Rauch, Carmen, additional, Dehan, MM. Michel, additional, Claris, Olivier, additional, Goffinet, François, additional, Marpeau, Loïc, additional, and Subtil, Damien, additional

Published
2006
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198. Rapport 23-07. Santé à moyen et à long terme des enfants conçus par fécondation in vitro (FIV)

Author

Jouannet, Pierre, Claris, Olivier, and Le Bouc, Yves

Abstract

Parmi les questions médicales, scientifiques et éthiques suscitées par l’assistance médicale à la procréation et notamment la fécondation in vitro (FIV), celles concernant la santé à moyen et à long terme des enfants et des jeunes adultes sont primordiales. De nombreuses études ont été menées s’intéressant à la survenue de différentes altérations de la santé, notamment les troubles de la croissance et du métabolisme, les troubles cardiovasculaires, les pathologies liées aux gènes soumis à empreinte, les cancers pédiatriques, les troubles du neurodéveloppement et de la fertilité. Les résultats publiés ne sont pas tous concordants. Il en ressort globalement que les enfants conçus par FIV peuvent être parfois atteints de troubles de la santé sans qu’un type particulier prédomine, que leur incidence est relativement modérée et qu’en cas d’augmentation significative de l’incidence, elle n’est pas beaucoup plus importante que chez les enfants conçus naturellement. Cependant les études comparatives faites sur des populations mieux caractérisées doivent être poursuivies, notamment à des âges plus avancés de la vie. Les altérations observées chez les enfants ne sont pas forcément imputables à la FIV dans la mesure où les couples infertiles peuvent être plus à risque de transmettre à leurs enfants des facteurs responsables de perturbations de santé. Par exemple, certains garçons nés à la suite d’une FIV avec microinjection de spermatozoïde dans l’ovocyte (ICSI), faite pour pallier une infertilité masculine d’origine génétique, risquent d’être stériles comme leur père. Parmi les procédures utilisées pour réaliser une FIV, ce sont les traitements hormonaux de stimulation ovarienne, les conditions de la culture embryonnaire et la congélation des embryons qui sont le plus souvent suspectés d’être à l’origine des troubles observés. Il serait donc nécessaire que ces procédures soient précisément documentées dans les études publiées et dans les bases de données élaborées pour analyser l’activité. Les mécanismes impliqués dans la survenue des altérations observées sont mal connus. Si des perturbations de régulations épigénétiques sont le plus souvent évoquées, des recherches sur des modèles animaux mais aussi dans l’espèce humaine sont nécessaires pour les préciser. Le fait que beaucoup d’incertitudes demeurent ne devrait pas empêcher qu’une information claire, objective et précise, soit donnée aux personnes ayant recours à une FIV afin que puissent être prises les mesures les plus appropriées possible en cas d’apparition de troubles de santé chez leurs enfants.

Published
2023
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