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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Procedural Pain Response

Intervention / Treatment
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* Procedure: Co-bedding (caring for twins in the same incubator)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-bedding<br>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)<br>* 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).<br>|
| No Intervention: Standard care<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Co-bedding, Procedural pain, Twin, Comfort, RCT