Epidemiology of Painful Procedures in Neonates (EPIPPAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CARBAJAL, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT01346813
First received: May 2, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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:

  1. To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale.
  2. To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011.
  3. To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France.
  4. To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units
  5. To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units
  6. To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results

Condition
Newborn Morbidity
Pain
Procedures
Intratracheal Intubation
Analgesia
Intensive Care
Longterm Effects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Hôpital Armand Trousseau:

Estimated Enrollment: 1000
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 45 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

Intensive care units:

  • Neonates admitted to the unit during the 6-week recruitment period
  • Age less than 45 post-conceptional weeks

Regional pediatric transport system (SMUR):

  • Neonates transported during the 2-months recruitment period
  • Age less than 45 post-conceptional weeks

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346813

Locations
France
Hôpital Victor Dupouy. Service de réanimation néonatale
Argenteuil, France, 95107
Hôpital Antoine Béclère. Service de réanimation néonatale
Clamart, France, 92141
SMUR 92 Clamart
Clamart, France, 92141
Hôpital Louis Mourier. Service de réanimation néonatale
Colombes, France, 92701
CHI Créteil. Service de réanimation néonatale
Créteil, France, 94000
Hôpital du Sud Francilien. Service de réanimation néonatale
Evry, France, 91014
Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale
Le Kremlin-Bicêtre, France, 94275
Hôpital de Meaux. Service de réanimation néonatale
Meaux, France, 77104
CHI André Grégoire. Service de réanimation néonatale
Montreuil, France, 93100
SAMU 93 Montreuil
Montreuil, France, 93100
Hôpital Armand Trousseau. Service de Réanimation Pédiatrique
Paris, France, 75012
Hôpital Cochin-Port Royal. Service de médecine néonatale
Paris, France, 75014
Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale
Paris, France, 75014
Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale
Paris, France, 75015
Hôpital Robert Debré. Service de réanimation néonatale
Paris, France, 75019
SMUR 75 Necker
Paris, France, 75015
SMUR 75 Robert Debré
Paris, France, 75019
Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale
Poissy, France, 78300
SAMU 95 Pontoise
Pontoise, France, 95303
Centre Hospitalier René Dubos. Service de réanimation néonatale
Pontoise, France, 95303
Hôpital Delafontaine. Service de réanimation néonatale
Saint Denis, France, 93205
Sponsors and Collaborators
Hôpital Armand Trousseau
Investigators
Principal Investigator: Ricardo Carbajal, MD, PhD Hôpital Armand Trousseau, Paris, France
  More Information

No publications provided

Responsible Party: CARBAJAL, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT01346813     History of Changes
Other Study ID Numbers: EPIPPAIN2_IDF
Study First Received: May 2, 2011
Last Updated: October 24, 2011
Health Authority: France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Hôpital Armand Trousseau:
Newborns
Premature
Pain
Pain assessment
Painful Procedures
Stressful Procedures
Endotracheal Intubation
Analgesia
Sedation
Longterm effects of pain
Epidemiology

ClinicalTrials.gov processed this record on August 28, 2014