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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03055039
Other study ID # EPIDROOM
Secondary ID
Status Completed
Phase N/A
First received February 10, 2017
Last updated September 4, 2017
Start date February 19, 2016
Est. completion date May 31, 2016

Study information

Verified date September 2017
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy. During the delivery the baby is exposed to multiple exterior factors and he is capable to memorize the pain .Recent epidemiologic studies showed that the coverage of pain was insuffcient and also an increase of analgesic means. Normally the pain coverage have to be managed and group every painful gesture. In fact all these recommandations are not followed by medical team.

The aim of the study is to evaluate the prevalence of this type of pain as to set up an adequate coverage.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date May 31, 2016
Est. primary completion date March 2, 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Days
Eligibility Inclusion Criteria:

- Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room

Exclusion Criteria:

- Newborn child been born in palliative care

- non francophone parents

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of prevalence of the newborn child 's pain in delivery room Counting the number of painful gesture (injection,blood test...) Day 1