The Holding Study: Feeding Analgesia in Preterm Infants

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT00414258
• Lead Sponsor: University of British Columbia

Brief Summary

The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.

2. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Detailed Description

Research Method:

In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-12
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Born between 30-35 weeks gestational age
• Mother has fluent English

Exclusion Criteria

• CNS injury
• congenital anomaly
• active infection
• has had no surgeries or analgesics/sedatives in last 72 hours
• history of maternal drug exposure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate

Secondary Outcome Measures

Name	Time	Method
Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
Samples taken at baseline and recovery;Salivary Cortisol sample

Trial Locations

Locations (1)

Children's and Women's Health Centre of British Columbia, Special Care Nursery; 🇨🇦 Vancouver, British Columbia, Canada