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Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by University of Cologne.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926445
First Posted: June 23, 2009
Last Update Posted: June 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Cologne
  Purpose
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.

Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Neonatal Pain- and Distress Experiences on Later Pain Behaviour of Former Preterm and Critically Ill Newborn Infants

Further study details as provided by University of Cologne:

Biospecimen Description:
Saliva for measuring cortisol levels

Estimated Enrollment: 120
Study Start Date: November 2008
Groups/Cohorts
Preterm (BW < 1500 grams)
Critically ill term newborn
ventilation > 48 hours
Healthy term newborn

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Preterm < 1500 grams BW, critically ill term newborn on ventilation > 48 hours

Exclusion Criteria:

  • Asphyxia
  • ICH grade 3 and higher
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926445


Locations
Germany
Neonatologische Intensivstation Recruiting
Cologne, NRW, Germany, 50931
Contact: Katrin Mehler, MD    0049221478 ext 5998    Katrin.Mehler@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
  More Information

Responsible Party: University of Cologne, Christoph Huenseler
ClinicalTrials.gov Identifier: NCT00926445     History of Changes
Other Study ID Numbers: 08-177
First Submitted: June 22, 2009
First Posted: June 23, 2009
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by University of Cologne:
Pain behavior

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes