Loading search results
EPIPPAIN
Epidémiologie Des Gestes Douloureux ou Stressants Chez Les Nouveau-nés Pris en Charge Dans Les unités de réanimation néonatale et pédiatrique et Par Les équipes de SMUR de la région d'Ile de France
Sponsor study identifier
observational
1,000
1 country
21
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
August 2011
Actual (reported)Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years. Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared. The objectives of the present study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2, 2011
Actual (reported)May 3, 2011
Actual (reported)August 2011
Actual (reported)August 2011
Actual (reported)Two settings: neonatal or pediatric intensive care units and regional pediatric transport system (SMUR). In intensive care units, during the first 14 days of admission prospective data will be collected on all neonatal procedures causing pain, stress, or discomfort with the corresponding analgesic therapy and pain assessment. A detailed record of conditions of endotracheal intubations will also be carried out. In the SMUR, neonates transported during the 2-months study period by all of 5 SMUR will have all their procedures recorded in a specific data collection form. A real-time assessment of pain induced by each procedure will be carried out by staff using the DAN scale. A detailed record of conditions and neonate tolerance of endotracheal intubations will also be carried out.
Hôpital Victor Dupouy. Service de réanimation néonatale
Argenteuil, 95107, France
Hôpital Antoine Béclère. Service de réanimation néonatale
Clamart, 92141, France
SMUR 92 Clamart
Clamart, 92141, France
Hôpital Louis Mourier. Service de réanimation néonatale
Colombes, 92701, France
CHI Créteil. Service de réanimation néonatale
Créteil, 94000, France
Hôpital du Sud Francilien. Service de réanimation néonatale
Évry, 91014, France
Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale
Carbajal R, Lode N, Ayachi A, Chouakri O, Henry-Larzul V, Kessous K, Normand A, Courtois E, Rousseau J, Cimerman P, Chabernaud JL. Premedication practices for tracheal intubation in neonates transported by French medical transport teams: a prospective observational study. BMJ Open. 2019 Nov 14;9(11):e034052. doi: 10.1136/bmjopen-2019-034052.
Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfevre C, Lagarde A, Sgaggero B, Guiot C, Goussot M, Huraux E, Nanquette MC, Butel C, Ferreira AM, Lacoste S, Sejourne S, Jolly V, Lajoie G, Maillard V, Guedj R, Chappuy H, Carbajal R. The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. 2016 May;57:48-59. doi: 10.1016/j.ijnurstu.2016.01.014. Epub 2016 Feb 8.
Ricardo Carbajal, MD, PhD
Hôpital Armand Trousseau, Paris, France
First Submitted
May 2, 2011
First Posted
May 3, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Contact the study team to confirm eligibility.
Le Kremlin-Bicêtre, 94275, France
Hôpital de Meaux. Service de réanimation néonatale
Meaux, 77104, France
CHI André Grégoire. Service de réanimation néonatale
Montreuil, 93100, France
SAMU 93 Montreuil
Montreuil, 93100, France
Hôpital Armand Trousseau. Service de Réanimation Pédiatrique
Paris, 75012, France
Hôpital Cochin-Port Royal. Service de médecine néonatale
Paris, 75014, France
Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale
Paris, 75014, France
Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale
Paris, 75015, France
SMUR 75 Necker
Paris, 75015, France
Hôpital Robert Debré. Service de réanimation néonatale
Paris, 75019, France
SMUR 75 Robert Debré
Paris, 75019, France
Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale
Poissy, 78300, France
Centre Hospitalier René Dubos. Service de réanimation néonatale
Pontoise, 95303, France
SAMU 95 Pontoise
Pontoise, 95303, France
Hôpital Delafontaine. Service de réanimation néonatale
Saint-Denis, 93205, France
Study Completion
August 2011
Actual (reported)Last Updated
October 26, 2011
Record last verified: 2011-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: