EUROpean Pain Audit In Neonates (EUROPAINsurvey)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CARBAJAL, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT01694745
First received: September 25, 2012
Last updated: January 22, 2014
Last verified: February 2013
  Purpose

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study.

The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries.

The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes.

The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception.

The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.


Condition
Pain
Analgesia
Sedation
Intesive Care
Intratracheal Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units

Further study details as provided by Hôpital Armand Trousseau:

Primary Outcome Measures:
  • The frequency of ventilated neonates receiving sedation and analgesia in different European units [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The medications used for sedation and analgesia in ventilated neonates across Europe [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The length of use of medications administered for sedation and analgesia in ventilated neonates [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Similarities and differences in sedation and analgesia practices among European countries [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 6489
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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
  • All neonates up to a corrected age of 44 weeks post conception. That means, for example, that a baby of 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.
  • The aim of including all neonates is to both ensure a generalization of the findings to all ventilated and non ventilated neonates admitted to intensive care units and to obtain a clear description of practices across Europe.
Criteria

Inclusion Criteria:

  • • All neonates up to a corrected age of 44 weeks post conceptional. That means, for example, that an infant born at 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.

NOTE: Since this is an observational epidemiological study, all eligible infants of the unit during the study period should be included.

Exclusion Criteria:

  • • The only exclusion criteria of this observational study is the participation of the neonate in a research study including a randomization for the use of sedative or analgesic drugs in ventilated neonates.
  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: NCT01694745

  Show 242 Study Locations
Sponsors and Collaborators
Hôpital Armand Trousseau
Investigators
Principal Investigator: Ricardo Carbajal, MD PhD Armand Trousseau
  More Information

Additional Information:
No publications provided

Responsible Party: CARBAJAL, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT01694745     History of Changes
Other Study ID Numbers: EUROPAIN Survey
Study First Received: September 25, 2012
Last Updated: January 22, 2014
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
France: The Commission nationale de l’informatique et des libertés

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

ClinicalTrials.gov processed this record on August 28, 2014