New Born Child PainNCT03055039
Epidemiology of Pain in the Delivery Room
An observational study of New Born Child Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- New Born Child Pain
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2016to 31 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room
Who may be able to join
- Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room
Who cannot join
- Newborn child been born in palliative care
- non francophone parents
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Epidemiology of New Born Child Pain in the Delivery Room
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.
- Conditions
- New Born Child Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of prevalence of the newborn child 's pain in delivery room
Counting the number of painful gesture (injection,blood test...)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start19 Feb 2016
- Primary completion2 Mar 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Born Child PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055039
- Sponsor's protocol ID
- EPIDROOM
- Status last verified
- Sep 2017
- First submitted
- 10 Feb 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of New Born Child Pain in the Delivery Room
- ClinicalTrials.gov ID
- NCT03055039
- Acronym / sponsor ID
- EPIDROOM
- Conditions
- New Born Child Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 2 Mar 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room
Key inclusion criteria (1 listed)
- Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room
Key exclusion criteria (2 listed)
- Newborn child been born in palliative care
- non francophone parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of prevalence of the newborn child 's pain in delivery room
Time frame: Day 1
Counting the number of painful gesture (injection,blood test...)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Born Child Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of prevalence of the newborn child 's pain in delivery room (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.