The Holding Study: Feeding Analgesia in Preterm Infants

Pain Clinical Trial

Official title:

The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414258
• Other study ID #: C06 - 0347
• Status: Completed
• Phase: N/A
• First received: December 19, 2006
• Last updated: April 12, 2011
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• breastfeeding
See detailed description.

Locations

Country	Name	City	State
Canada	Children's and Women's Health Centre of British Columbia, Special Care Nursery	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate		Unspecified	No
Secondary	Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States		Unspecified	No
Secondary	Samples taken at baseline and recovery;Salivary Cortisol sample		Unspecified	No