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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917631
First Posted: June 10, 2009
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marsha Campbell-Yeo, IWK Health Centre
  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)

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

Further study details as provided by Marsha Campbell-Yeo, IWK Health Centre:

Primary Outcome Measures:
  • Pain response(Premature Infant Pain Profile (PIPP) [ Time Frame: Baseline until completion of heelstick ]

Secondary Outcome Measures:
  • Recovery [ Time Frame: The length of time for heart rate and oxygen saturation to return to normal (baseline). ]
  • Vagal tone [ Time Frame: Baseline until completion of heelstick ]
  • Hormonal stress response (Cortisol) [ Time Frame: Baseline and 20 minutes post heelstick ]
  • Frequency of 24% sucrose administration [ Time Frame: Baseline to completion of the heelstick ]
  • The response of the co-twin not receiving the painful procedure [ Time Frame: Baseline to completion of the heelstick ]

Enrollment: 134
Study Start Date: December 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Co-bedding

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).

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
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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917631


Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Marsha L Campbell-Yeo, MN NNP-BC PhDc IWK Health Centre