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

Not Applicable

Completed

• Conditions: Neonatal Procedural Pain Response

• Registration Number: NCT00917631
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain response(Premature Infant Pain Profile (PIPP)	Baseline until completion of heelstick

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada