Trial record 7 of 21 for:    Open Studies | "Twins"

Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures (CComforT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by IWK Health Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00917631
First received: June 8, 2009
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Condition Intervention
Neonatal Procedural Pain Response
Procedure: Co-bedding (caring for twins in the same incubator)
Other: Standard care - No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Pain response(Premature Infant Pain Profile (PIPP) [ Time Frame: Baseline until completion of heelstick ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery [ Time Frame: The length of time for heart rate and oxygen saturation to return to normal (baseline). ] [ Designated as safety issue: No ]
  • Vagal tone [ Time Frame: Baseline until completion of heelstick ] [ Designated as safety issue: No ]
  • Hormonal stress response (Cortisol) [ Time Frame: Baseline and 20 minutes post heelstick ] [ Designated as safety issue: No ]
  • Frequency of 24% sucrose administration [ Time Frame: Baseline to completion of the heelstick ] [ Designated as safety issue: No ]
  • The response of the co-twin not receiving the painful procedure [ Time Frame: Baseline to completion of the heelstick ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Co-bedding Procedure: Co-bedding (caring for twins in the same incubator)

Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding.

Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary.

Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes).

No Intervention: Standard care Other: Standard care - No intervention
For infants who are randomized to receive standard care, the twin pair will remain in separate incubators as per current NICU policy. The infant will be nested in boundaries consistent with neonatal care practices. The heelstick may occur at any time following randomization (within 10 days) to maintain consistency between groups.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All medically stable twin infants admitted to the NICU who are:

    1. Free from infection; and
    2. Breathing room air or receiving oxygen via nasal prongs.
  • Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.

Exclusion Criteria:

  • Weigh less than 1000 grams;
  • Receiving ventilator support;
  • Have chest tubes or umbilical catheter in situ;
  • Have major congenital anomalies or chromosomal aberrations; OR
  • If only one of the twins require overhead phototherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917631

Contacts
Contact: Marsha L Campbell-Yeo, MN NNP-BC PhDc 902 470-8895 marsha.campbellyeo@iwk.nshealth.ca
Contact: Kim Caddell, BScN 902 470-6704 kim.caddell@iwk.nshealth.ca

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Diann Nicholson    470      
Principal Investigator: Marsha L Campbell-Yeo, MN NNP-BC PhDc         
Sub-Investigator: Celeste C Johnston, RN D.Ed         
Sub-Investigator: K S Joseph, MD PhD         
Sub-Investigator: Christine Chambers, R.Psych PhD         
Sub-Investigator: Nancy Feeley, RN PhD         
Sub-Investigator: Keith Barrington, MD         
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Marsha L Campbell-Yeo, MN NNP-BC PhDc IWK Health Centre
  More Information

No publications provided by IWK Health Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marsha Campbell-Yeo, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00917631     History of Changes
Other Study ID Numbers: #4382
Study First Received: June 8, 2009
Last Updated: June 9, 2009
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by IWK Health Centre:
Co-bedding
Procedural pain
Twin
Comfort
RCT

ClinicalTrials.gov processed this record on August 28, 2014