Trial of Repeated Analgesia With Kangaroo Care

NCT01561547 | Completed Phase 3

• 2 other identifiers: TRAKCCIHR-NSHRF-Mayday RPP 2446
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied. AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

Conditions

Pain; Development

Keywords

pain; preterm neonate; sucrose; kangaroo mother care

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile (PIPP)

  The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.

  At the moment of painful procedure

Secondary Outcomes (1)

• Neurobehavioral Assessment of Preterm Infants (NAPI)

  32, 36 and 40 weeks gestational age

Study Arms (3)

Kangaroo Mother Care

EXPERIMENTAL

Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.

Behavioral: Kangaroo Mother Care

Sucrose

ACTIVE COMPARATOR

Two minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important.

Dietary Supplement: Sucrose

Combination Kangaroo Mother Care and Sucrose

EXPERIMENTAL

Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.

Behavioral: Kangaroo Mother Care; Dietary Supplement: Sucrose

Interventions

Kangaroo Mother Care BEHAVIORAL

Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.

Combination Kangaroo Mother Care and Sucrose; Kangaroo Mother Care

Sucrose DIETARY_SUPPLEMENT

24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.

Combination Kangaroo Mother Care and Sucrose; Sucrose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• less than 36.0 weeks gestational age
• mother is generally available to provide kangaroo mother care

You may not qualify if:

• narcotic analgesics
• surgery in past 48 hrs
• major congenital anomalies

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Nova Scotia Health Research Foundation: collaborator
• Mayday Fund: collaborator

Study Sites (1)

IWKHealthC

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (7)

• Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.

  PMID: 21893645 BACKGROUND

• Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13.

  PMID: 18435837 BACKGROUND

• Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.

  PMID: 14609899 BACKGROUND

• Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.

  PMID: 12205254 BACKGROUND

• Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.

  PMID: 20091512 BACKGROUND

• Vinall J, Noel M, Disher T, Caddell K, Campbell-Yeo M. Memories of Infant Pain in the Neonatal Intensive Care Unit Influence Posttraumatic Stress Symptoms in Mothers of Infants Born Preterm. Clin J Pain. 2018 Oct;34(10):936-943. doi: 10.1097/AJP.0000000000000620.

  PMID: 29698249 DERIVED

• Campbell-Yeo M, Johnston C, Benoit B, Latimer M, Vincer M, Walker CD, Streiner D, Inglis D, Caddell K. Trial of repeated analgesia with Kangaroo Mother Care (TRAKC Trial). BMC Pediatr. 2013 Nov 9;13:182. doi: 10.1186/1471-2431-13-182.

  PMID: 24284002 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Kangaroo-Mother Care Method; Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Celeste Johnston, RN, DEd

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

• Marsha Campbell-Yeo, RN, NNP, PhD

  IWK Health Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 23, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)