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

Not Applicable

Completed

• Conditions: Neonatal Procedural Pain Response
• Interventions: Procedure: Co-bedding (caring for twins in the same incubator)

• 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

Arm && Interventions

Group	Intervention	Description
Co-bedding	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).

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