Condition category
Signs and Symptoms
Date applied
19/07/2007
Date assigned
03/10/2007
Last edited
03/10/2007
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
H3A 2A7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A09-B33-06A

Study information

Scientific title

Acronym

AFKC

Study hypothesis

Primary hypothesis:
There will be no difference in pain response and time to recovery 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 Alternative Female Kangaroo Care (AFKC).

Ethics approval

Study approved by McGill University Institutional Review Board (IRB) on 11th September 2006 (ref: A09-B33-06A).

Study design

This study is a test of non-inferiority or alternate mother KC versus maternal KC. It is a crossover design where neonates served as their own control.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pain response

Intervention

After obtained informed consent from the mother and the alternative female, the neonate will be randomised to:
1. Control group: mother first and alternative female second, or
2. Treatment group: alternative female first and mother second

Kangaroo Care involves placing a diaper-clad neonate at an angle of sixty degrees between the breasts providing maximal skin-to-skin contact between the infant and the caregiver. The neonate is placed in KC for 15 minutes before the painful procedure (heelstick) performed by a hospital technician assigned to the study. The alternative female will wear a mask if she did not visit her general practioner for good health within two days of the treatment condition.

All alternate females will wash their chest with an non-scented soap common to the NICU and will respect the hand washing procedures recommended by the NICU. 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 one with the alternative female. The measures will be taken for the entire heel-lance procedure (one minute baseline, one minute warming of the neonate's foot, stick, extraction of the blood and return to baseline).

Second sponsor:
Canadian Nurses Foundation (Canadian Nurses Fondation [CNF])
50 Driveway
Ottawa, Ontario
K2P 1E2
Canada

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain measured with Premature Infant Pain Profile (PIPP)
2. Facial actions of the PIPP scored according to Neonatal Facial Coding System (NFCS)

Secondary outcome measures

Time for return to physiological baseline measured as the preterm neonate's return to baseline Heart Rate (HR) after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate.

Overall trial start date

11/09/2006

Overall trial end date

11/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born between 28 0/7 weeks and 36 6/7 gestational age
2. Obtained consent
3. Receiving at least two heel lances prior to discharge
4. Within 10 days of hospitalisation
5. Neonate has to be stable according to the Neonatal Intensive Care Unit criteria
6. Alternate female had to be healthy and older than 18 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

N = 64, power = 0.8, alpha = 0.05 using the PIPP with a difference of 1 point of the PIPP scale.

Participant exclusion criteria

Does not comply with the inclusion criteria.

Recruitment start date

11/09/2006

Recruitment end date

11/09/2008

Locations

Countries of recruitment

Canada

Trial participating centre

3506 University, room 226
Montreal
H3A 2A7
Canada

Sponsor information

Organisation

Montreal Inter-University Group for Nursing Research (GRISIM) (Canada)

Sponsor details

3875
rue St-Urbain
Bureau 205
Montreal
H2W 1V1
Canada

Sponsor type

Research organisation

Website

http://www.grisim.ca/index.php?L=1

Funders

Funder type

Research organisation

Funder name

Quebec Health Research Fund (Fonds de recherche en Santé du Québec [FRSQ])/Montreal Inter-University Group for Nursing Research (Groupe de Recherche Interuniversitaire en Sciences Infirmières de Montréal [GRISIM]) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Nurses Foundation (Canadian Nurses Fondation [CNF]) (Canada)

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

Publication citations

Additional files

Editorial Notes