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

NCT ID: NCT00926445

Last Updated: 2009-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm (BW < 1500 grams)

No interventions assigned to this group

Critically ill term newborn

ventilation \> 48 hours

No interventions assigned to this group

Healthy term newborn

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Asphyxia
* ICH grade 3 and higher
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Christoph Huenseler

Locations

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Neonatologische Intensivstation

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Katrin Mehler, MD

Role: primary

0049221478 ext. 5998

Other Identifiers

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08-177

Identifier Type: -

Identifier Source: org_study_id

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