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

Primary Purpose

Neonatal Procedural Pain Response

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Co-bedding (caring for twins in the same incubator)
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Procedural Pain Response focused on measuring Co-bedding, Procedural pain, Twin, Comfort, RCT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Co-bedding

Standard care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Pain response(Premature Infant Pain Profile (PIPP)

Secondary Outcome Measures

Recovery
Vagal tone
Hormonal stress response (Cortisol)
Frequency of 24% sucrose administration
The response of the co-twin not receiving the painful procedure

Full Information

First Posted
June 8, 2009
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00917631
Brief Title
Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Acronym
CComforT
Official Title
Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Procedural Pain Response
Keywords
Co-bedding, Procedural pain, Twin, Comfort, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Co-bedding
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Co-bedding (caring for twins in the same incubator)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain response(Premature Infant Pain Profile (PIPP)
Time Frame
Baseline until completion of heelstick
Secondary Outcome Measure Information:
Title
Recovery
Time Frame
The length of time for heart rate and oxygen saturation to return to normal (baseline).
Title
Vagal tone
Time Frame
Baseline until completion of heelstick
Title
Hormonal stress response (Cortisol)
Time Frame
Baseline and 20 minutes post heelstick
Title
Frequency of 24% sucrose administration
Time Frame
Baseline to completion of the heelstick
Title
The response of the co-twin not receiving the painful procedure
Time Frame
Baseline to completion of the heelstick

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All medically stable twin infants admitted to the NICU who are: Free from infection; and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marsha L Campbell-Yeo, MN NNP-BC PhDc
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24300226
Citation
Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ, Walker CD. Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial. Clin J Pain. 2014 Jul;30(7):598-604. doi: 10.1097/AJP.0000000000000015.
Results Reference
derived
PubMed Identifier
22926182
Citation
Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ. Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial. Pediatrics. 2012 Sep;130(3):500-6. doi: 10.1542/peds.2012-0010. Epub 2012 Aug 27.
Results Reference
derived
PubMed Identifier
20003351
Citation
Campbell-Yeo ML, Johnston CC, Joseph K, Feeley NL, Chambers CT, Barrington KJ. Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial). BMC Pediatr. 2009 Dec 11;9:76. doi: 10.1186/1471-2431-9-76.
Results Reference
derived

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

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