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Table 1 Key variables, measures proposed, data sources, and time of administration

From: Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial)

Variables

Measures

Method/Sources

Time of administration

Pain response

Premature Infant Pain

Profile (PIPP)

Videotape of facial

responses

Baseline, warming

heelstick and recovery

Physiologic

recovery

Heart rate,

Oxygen saturation

Somté software

Baseline, warming

heelstick and recovery

Heart rate variability

Cardiac monitoring

Somté software

Baseline, warming

heelstick and recovery

Hormonal

stress response

Cortisol

Sorbette oral swab

Prior to heelstick (basal) and 20 minutes after (stress) the heel stick

Frequency of

24% sucrose

administration

Count

Chart medication record, confirmed with videotape recording

2 minute prior and during intervention

Co-twin

Response

All measures identical to the twin undergoing heelstick, except sucrose count

Identical measures, except sucrose count

Baseline, warming

heelstick and recovery

Safety surveillance

Caregiver error

Infection rate

Institutional adverse event and

infection control surveillance

Quarterly

Clinical Stability

Supplemental oxygen

Incidence of apnea

Bradycardia

Chart review

Baseline, warming heelstick and recovery