NCT02749461

Brief Summary

The aims of this validation study are the testing of the Bernese Pain Scale for Neonates' (BPSN) psychometric properties. The variability of pain reactions related to behavioral and physiological patterns across time will also be examined. Furthermore, the influence of contextual factors on the variability of pain reactions across gestational age groups will be explored. The results will be used for modifications of the BPSN to account for contextual factors in future clinical pain assessment in neonates.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

April 12, 2016

Last Update Submit

August 2, 2017

Conditions

Pain Assessment

Keywords

preterm infantspainassessmentcontextual factorsdiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • Change in pain response across time

    Change and variability of pain response across different time points will be measured with the BPSN

    2-5 timepoints within the first 14 days of life

Secondary Outcomes (2)

  • Influence of individual contextual factors on pain response across time

    2-5 within the first 14 days of life

  • Psychometric testing of the BPSN

    2-5 timepoints within the first 14 days of life

Interventions

heel stickPROCEDURE

Consecutive routine blood sampling heel sticks

Eligibility Criteria

Age24 Weeks - 41 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study includes preterm infants born between 24 0/7 and 36 6/7 weeks of gestation and term infants born between 37 0/7 and 42 0/7 weeks of gestation if they are hospitalised in a NICU in the University Hospitals in Basel, Bern and Zurich (Switzerland).

You may qualify if:

  • Preterm infants born between 24 0/7 and 36 6/7 weeks of gestation will be included if they are expected to undergo 5 routine heel capillary blood samples during the first 14 days of life; if they are ventilated or not ventilated; and if their parents give informed consent.
  • Term infants born between 37 0/7 and 42 0/7 weeks of gestation will be included if they are expected to have at least 2 routine heel capillary blood samples during the first days of life and if their parents give informed consent.

You may not qualify if:

  • Grade III oder IV intraventricular haemorrhaging
  • Severe life-threatening malformation or suffer from any condition involving partial or total loss of sensitivity
  • pHa \< 7.15 (umbilical cord)
  • Surgery for any reason
  • Congenital malformation affecting brain circulation and cardiovascular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lawrence S. Bloomberg Faculty of Nursing and Faculties of Medicine and Dentistry, University of Toronto

Toronto, Canada

Location

Department of Neonatology, University Children's Hospital of Basel (UKBB)

Basel, Switzerland

Location

Neonatology, Children's Hospital, University Hospital of Bern

Bern, Switzerland

Location

Neonatology, University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (2)

  • Schenk K, Stoffel L, Burgin R, Stevens B, Bassler D, Schulzke S, Nelle M, Cignacco E. The influence of gestational age in the psychometric testing of the Bernese Pain Scale for Neonates. BMC Pediatr. 2019 Jan 15;19(1):20. doi: 10.1186/s12887-018-1380-8.

    PMID: 30646872DERIVED

  • Cignacco E, Schenk K, Stevens B, Stoffel L, Bassler D, Schulzke S, Nelle M. Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study. BMC Pediatr. 2017 Jul 19;17(1):171. doi: 10.1186/s12887-017-0914-9.

    PMID: 28724434DERIVED

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Cignacco, Prof. Dr.

    Bern University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 25, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)CH(3)