Condition category
Signs and Symptoms
Date applied
16/02/2009
Date assigned
31/03/2009
Last edited
02/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Celeste Johnston

ORCID ID

Contact details

3506 University
room 226
Montreal
QC
H3A 2A7
Montreal
H3A 2A7
Canada
+1 514 398 4157
celeste.johnston@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2580; MOP-64307

Study information

Scientific title

Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation): a randomised controlled crossover trial

Acronym

FKC

Study hypothesis

There will be a difference in pain response, time to recovery and heart rate variability (HRV) from heel lance in 28 - 36 weeks gestational age Neonatal Intensive Care Unit (NICU) preterm neonates when they are engaged in maternal kangaroo care (KC) compared to when they are engaged in father's KC.

Ethics approval

CHU St-Justine Research Ethics Board (REB) gave approval on the 16th July 2007 (ref: 2580)

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain response during heel lancing

Intervention

After obtained informed consent from the mother and the father, the neonate will be randomised to intervention (father first mother second) or control (mother first father second). Kangaroo care involves placing a diaper-clad neonate at an angle of sixty degrees between the breasts or on the chest providing maximal skin-to-skin contact between the infant and the caregiver. The neonate is placed in KC 15 minutes before the painful procedure (heel lance) performed by a hospital technician assigned to the study. The heel lance procedure is relatively standardised across staff and timing and is an aspect of routine care for hospitalised preterm neonates. Each neonate will have two KC sessions filmed; one with the mother and the other one with the father. The measures will be taken for the entire heel lance procedure (one minute of baseline isolette, one minute of baseline kangaroo, one minute of warming, extraction of the blood and return to baseline kangaroo and isolette.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain measured with Premature Infant Pain Profile (PIPP), repeated over 30 second blocks
2. Facial actions of the PIPP scored according to Neonatal Facial Coding System (NFCS)

Secondary outcome measures

Timing for return to physiologic baseline measured as the preterm neonate's return to baseline HR after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate.

Overall trial start date

01/10/2007

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born between 28 0/7 and 35 6/7 weeks of gestation, either sex
2. Obtained consent
3. Receiving at least two heel lances prior to discharge
4. Within 10 days of hospitalisation
5. Stable according to Neonatal Intensive Care Unit criteria

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Genetic or major congenital disorders
2. Requiring surgery before or during the study period
3. Receiving analgesics or paralysing agents
4. Intra-ventricular haemorrhage (IVH) grade III+ or periventricular leukomalacia (PVL) as confirmed by ultrasound

Recruitment start date

01/10/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Canada

Trial participating centre

3506 University, room 226
Montreal
H3A 2A7
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

c/o Dr Celeste Johnston
School of Nursing
3506 University
Room 226
Montreal
H3A 2A7
Canada
+1 514 398 4157
celeste.johnston@mcgill.ca

Sponsor type

University/education

Website

http://www.mcgill.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-64307)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21893645

Publication citations

  1. Results

    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, 165, 9, 792-796, doi: 10.1001/archpediatrics.2011.130.

Additional files

Editorial Notes