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

September 1, 2016 updated by: Marsha Campbell-Yeo, IWK Health Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain response(Premature Infant Pain Profile (PIPP)
Time Frame: Baseline until completion of heelstick
Baseline until completion of heelstick

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery
Time Frame: The length of time for heart rate and oxygen saturation to return to normal (baseline).
The length of time for heart rate and oxygen saturation to return to normal (baseline).
Vagal tone
Time Frame: Baseline until completion of heelstick
Baseline until completion of heelstick
Hormonal stress response (Cortisol)
Time Frame: Baseline and 20 minutes post heelstick
Baseline and 20 minutes post heelstick
Frequency of 24% sucrose administration
Time Frame: Baseline to completion of the heelstick
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
Baseline to completion of the heelstick

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (ESTIMATE)

June 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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