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OpenTrials
Completed

NCT Number: NCT00917631

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Co-bedding (caring for twins in the same incubator)

Procedure

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 outcomes

  1. Pain response(Premature Infant Pain Profile (PIPP)

    Time frame: Baseline until completion of heelstick

Secondary outcomes

  1. Recovery

    Time frame: The length of time for heart rate and oxygen saturation to return to normal (baseline).

  2. Vagal tone

    Time frame: Baseline until completion of heelstick

  3. Hormonal stress response (Cortisol)

    Time frame: Baseline and 20 minutes post heelstick

  4. Frequency of 24% sucrose administration

    Time frame: Baseline to completion of the heelstick

  5. The response of the co-twin not receiving the painful procedure

    Time frame: Baseline to completion of the heelstick

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Acronym: CComforT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2009
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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