EUROpean Pain Audit In Neonates (EUROPAINsurvey)
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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 |
- The frequency of ventilated neonates receiving sedation and analgesia in different European units [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 ]
- 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 ]
| Estimated Enrollment: | 2303 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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 |
- 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.
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| Contact: Ricardo Carbajal, MD PhD | +33 144736487 | ricardo.carbajal@trs.aphp.fr |
| Contact: Emilie Courtois, RN | +33 144736451 | emilie.courtois@trs.aphp.fr |
Show 244 Study Locations| 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: | May 2, 2013 |
| 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 May 23, 2013