- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926445
Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants
June 22, 2009 updated by: University of Cologne
Effect of Neonatal Pain- and Distress Experiences on Later Pain Behaviour of Former Preterm and Critically Ill Newborn Infants
Preterm and critically ill neonates experience many painful manipulations.
The aim of the study is to evaluate the influence of these experiences and maternal deprivation on later pain behavior.
Using Scoring systems, Prechtl general movements, skin conductance, testing flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the investigators compare pain behavior of preterm (birth weight (BW) < 1500 grams), term neonates with need of ventilation (> 48 hours) with healthy neonates at the time of their first vaccination at the age of 3-4 months.
The investigators are also testing flexor reflexes and skin conductance and general movements in regular intervals during the initial hospital stay.
The investigators hypothesize that pain behavior is different at the age of 3-4 months in children with many early painful experiences.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50931
- Recruiting
- Neonatologische Intensivstation
-
Contact:
- Katrin Mehler, MD
- Phone Number: 5998 0049221478
- Email: Katrin.Mehler@uk-koeln.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 week (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Premature, critically ill term infants are recruited from the NICU of the University hospital of Cologne.
Healthy newborns are recruited from the nursery of the University hospital of Cologne.
Description
Inclusion Criteria:
- Preterm < 1500 grams BW, critically ill term newborn on ventilation > 48 hours
Exclusion Criteria:
- Asphyxia
- ICH grade 3 and higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Preterm (BW < 1500 grams)
|
Critically ill term newborn
ventilation > 48 hours
|
Healthy term newborn
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 22, 2009
First Posted (Estimate)
June 23, 2009
Study Record Updates
Last Update Posted (Estimate)
June 23, 2009
Last Update Submitted That Met QC Criteria
June 22, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-177
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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