Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit

NCT00758511 | Completed Early Phase 1

• 1 other identifier: 3200B1_122676
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care units are either "off label used" or "non-licensed" used. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population. This multicenter pilot study will use a randomized three group,repeated measures design. The primary aims of this study of premature neonates are to: 1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking alone, sucrose alone and sucrose in combination with tucking)on pain reactivity. 2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact of the numbers of painful procedures the infant experiences and the concurrent use of analgesic medications on the estimates of efficacy

Conditions

Preterm Infants

Keywords

cortisol; pain; pain management; preterm infants; sucrose; facilitated tucking

Outcome Measures

Primary Outcomes (1)

• Pain reaction

  first 14 days of life

Study Arms (3)

1

ACTIVE COMPARATOR

Orally administrated 25%sucrose before,during and after heel stick across 5 heel sticks during the first 14 days of postnatal life

Procedure: 25% Sucrose

2

ACTIVE COMPARATOR

facilitated tucking before, during and after heel stick across 5 heel stick during the first 14 days of postnatal life

Procedure: facilitated tucking

3

ACTIVE COMPARATOR

orally administrated 25% sucrose AND facilitated tucking before, during and after heel stick across 5 heel sticks during the first 14 days of postnatal life

Procedure: Sucrose and facilitated tucking

Interventions

25% Sucrose PROCEDURE

orally administrated 25%Sucrose before, during and after heel stick

1

facilitated tucking PROCEDURE

facilitated tucking before, during and after heel stick

2

Sucrose and facilitated tucking PROCEDURE

orally administrated 25%sucrose and facilitated tucking before, during and after heel stick

3

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• must be born between 24 0/7 and 32 0/7 weeks of gestation
• must be hospitalized in the NICU
• it must be anticipated that they will need at least 5 routine heel sticks
• their parents give informed consent

You may not qualify if:

• had a high-grade intraventricular hemorrhaging (grade III and IV);
• have a severe, life-threatening malformations;
• are suffering from any condition involving partial or total loss of sensitivity
• had a pHa \< 7.00;
• had surgery for any reason; or
• have a congenital malformation affecting brain circulation or the cardiovascular system.

Sponsors & Collaborators

• University of Basel: lead
• University of Pittsburgh: collaborator
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Institute of Nursing Science Medical Faculty, University of Basel

Basel, 4056, Switzerland

Location

Related Publications (1)

• Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28.

  PMID: 23651076 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Sucrose; Facilitated Tucking

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eva EC Cignacco, PhD,MNSc, RM

  Institute of Nursing Science, medical Faculty, University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 15, 2013

Record last verified: 2010-02

Locations

CH (1)