APHP Hospital Robert Debre

Paris, France

APHP Hospital Robert Debre

Paris, France
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Turner M.A.,University of Liverpool | Duncan J.C.,Alder Hey Childrens NHS Foundation Trust | Shah U.,Alder Hey Childrens NHS Foundation Trust | Metsvaht T.,University of Tartu | And 11 more authors.
Advanced Drug Delivery Reviews | Year: 2014

Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues. © 2013 Elsevier B.V.


PubMed | Queen's University of Belfast, University of Liverpool, Alder Hey Childrens NHS Foundation Trust, University of Tartu and 3 more.
Type: | Journal: Advanced drug delivery reviews | Year: 2014

Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.


Rinaldi V.E.,APHP Hospital Robert Debre | Titomanlio L.,APHP Hospital Robert Debre
Italian Journal of Pediatrics | Year: 2014

Importance: Migraine is a common disorder and a frequent cause of medical consultation in children. Many childhood episodic syndromes have been described as common precursors of migraine. Objective: To review current knowledge on migraine and childhood episodic syndromes, and to discuss future directions for research and clinical practice. Findings: For most children it is difficult to describe a headache and fully verbalize symptoms such as photophobia and phonophobia that must be inferred from behaviour. Classical migraine features are rare before the age of 6 years, but some migraine-related syndromes have been described. Benign paroxysmal torticollis of infancy, benign paroxysmal vertigo of childhood, cyclic vomiting syndrome and abdominal migraine are currently classified as childhood episodic syndromes, and therefore common precursors of migraine. A strong association between infantile colic and migraine has recently been reported. There are similarities between children with episodic syndromes and children with migraine, regarding social and demographic factors, precipitating and relieving factors, and accompanying gastrointestinal, neurologic, and vasomotor features. The real pathophysiological mechanisms of migraine are not fully understood. Current data obtained through molecular and functional studies provide a complex model in which vascular and neurologic events cooperate in the pathogenesis of migraine attacks. Genetic factors causing disturbances in neuronal ion channels, make a migraineur more sensitive to multiple trigger factors that activate the nociception cascade. The expanding knowledge on migraine genetics and pathophysiology may be applicable to childhood episodic syndromes. Migraine preventive strategies are particularly important in children, and could be beneficial in childhood episodic syndromes. Nonspecific analgesics like ibuprofen and acetaminophen are widely used in pediatrics to control pain and have been found to be effective also in the treatment of acute migraine attacks. Triptans are the specific fist-line drugs for acute migraine treatment. Conclusions and relevance: Migraine phenotype differs somewhat in the developing brain, and childhood episodic syndromes may arise before typical migraine headache. Diagnosing pediatric migraine may be difficult because of children's language and cognitive abilities. The risk of underestimating migraine in pediatric age is high. An adequate diagnosis is important to maintain a good quality of life and to avoid inappropriate therapy. © 2014 Spiri et al.; licensee BioMed Central Ltd.


Romanello S.,APHP Hospital Robert Debre | Romanello S.,French Institute of Health and Medical Research | Spiri D.,University of Milan | Marcuzzi E.,APHP Hospital Robert Debre | And 16 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

Importance: Infantile colic is a common cause of inconsolable crying during the first months of life and has been thought to be a pain syndrome. Migraine is a common cause of headache pain in childhood. Whether there is an association between these 2 types of pain in unknown. Objective: To investigate a possible association between infantile colic and migraines in childhood. Design, Setting, and Participants: Acase-control study of 208 consecutive children aged 6 to 18 years presenting to the emergency department and diagnosed as having migraines in 3 European tertiary care hospitals between April 2012 and June 2012. The control group was composed of 471 children in the same age range who visited the emergency department of each participating center for minor trauma during the same period. A structured questionnaire identified personal history of infantile colic for case and control participants, confirmed by health booklets. A second study of 120 children diagnosed with tension-type headaches was done to test the specificity of the association. Main Outcomes and Measures: Difference in the prevalence of infantile colic between children with and without a diagnosis of migraine. Results: Children with migraine were more likely to have experienced infantile colic than those without migraine (72.6% vs 26.5%; odds ratio [OR], 6.61 [95% CI, 4.38-10.00]; P < .001), either migraine without aura (n=142; 73.9% vs 26.5%; OR, 7.01 [95% CI, 4.43-11.09]; P < .001), or migraine with aura (n=66; 69.7% vs 26.5%;OR, 5.73 [95% CI, 3.07-10.73]; P < .001). This association was not found for children with tension-type headache (35% vs 26.5%; OR, 1.46 [95% CI, 0.92-2.32]; P =.10). Conclusion and Relevance: The presence of migraine in children and adolescents aged 6 to 18 years was associated with a history of infantile colic. Additional longitudinal studies are required. ©2013 American Medical Association. All rights reserved.


PubMed | APHP Hospital Robert Debre
Type: Journal Article | Journal: JAMA | Year: 2013

Infantile colic is a common cause of inconsolable crying during the first months of life and has been thought to be a pain syndrome. Migraine is a common cause of headache pain in childhood. Whether there is an association between these 2 types of pain in unknown.To investigate a possible association between infantile colic and migraines in childhood.A case-control study of 208 consecutive children aged 6 to 18 years presenting to the emergency department and diagnosed as having migraines in 3 European tertiary care hospitals between April 2012 and June 2012. The control group was composed of 471 children in the same age range who visited the emergency department of each participating center for minor trauma during the same period. A structured questionnaire identified personal history of infantile colic for case and control participants, confirmed by health booklets. A second study of 120 children diagnosed with tension-type headaches was done to test the specificity of the association.Difference in the prevalence of infantile colic between children with and without a diagnosis of migraine.Children with migraine were more likely to have experienced infantile colic than those without migraine (72.6% vs 26.5%; odds ratio [OR], 6.61 [95% CI, 4.38-10.00]; P < .001), either migraine without aura (n = 142; 73.9% vs 26.5%; OR, 7.01 [95% CI, 4.43-11.09]; P < .001), or migraine with aura (n = 66; 69.7% vs 26.5%; OR, 5.73 [95% CI, 3.07-10.73]; P < .001). This association was not found for children with tension-type headache (35% vs 26.5%; OR, 1.46 [95% CI, 0.92-2.32]; P = .10).The presence of migraine in children and adolescents aged 6 to 18 years was associated with a history of infantile colic. Additional longitudinal studies are required.

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