Condition category
Pregnancy and Childbirth
Date applied
26/03/2006
Date assigned
27/06/2006
Last edited
27/03/2009
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 Street
Room 226
Montreal
H3A 2A7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MOP-64307

Study information

Scientific title

Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers

Acronym

Enhanced MotherCARE

Study hypothesis

Physiological pain and stress response will be lower in maternally enhanced skin-skin contact (SSC) than SSC in preterm neonates of 32 - 36 weeks.

Ethics approval

McGill University Health Centre (full board review) approved on the 20th November 2003 (ref: MCH003-48)

Study design

Randomised cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pain response

Intervention

Skin-to-skin contact: the diaper-clad infant will be held upright at an angle of sixty degrees between the breasts of the mother during a routine heel stick procedure. A blanket will be placed over the infants back throughout the intervention. The baby will remain in this condition for 15 minutes prior to heel lance, during the procedure and until the infant returns to baseline heart rate after the procedure is completed.

Maternally-enhanced skin-skin contact: throughout the procedure, the mother will be seated with her infant in a rocking chair and will be asked to recite rhymes or sing songs to her infant. This will begin 15 minutes prior to heel stick. Just before the heel stick procedure, she will be asked to insert the tip of her well-trimmed smallest finger into the baby's mouth for the baby to suck. One minute later, the procedure will begin by collecting baseline data.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physiologic stability:
1. Maximum range of heart rate and O2 saturation from baseline throughout the procedure
2. Time to return to baseline heart rate and O2 saturation

Secondary outcome measures

Stress response: measured through the procurement of salivary cortisol collected prior to (basal) and 30 minutes after (stress response) the heel stick procedure for both the mother and the infant.

Overall trial start date

01/12/2003

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born between 28 0/7 and 32 6/7 weeks post-menstrual age (PMA) as determined by an ultrasound will be eligible.

Participant type

Patient

Age group

Child

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, paralyzing agents or steroid therapy
4. Apgar scores less than 6 at five minutes
5. Intraventricular haemorrhage (IVH) grade III and/or periventricular leukomalacia (PVL) as confirmed by ultrasound

Recruitment start date

01/12/2003

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Canada

Trial participating centre

3506 University Street
Montreal
H3A 2A7
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

3506 University Street
Room 226
Montreal
H3A 2A7
Canada

Sponsor type

University/education

Website

http://www.mcgill.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institute 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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18769382

Publication citations

  1. Results

    Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Enhanced kangaroo mother care for heel lance in preterm neonates: a crossover trial., J Perinatol, 2009, 29, 1, 51-56, doi: 10.1038/jp.2008.113.

Additional files

Editorial Notes