NCT00414258

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. 1.When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
  2. 2.Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

December 19, 2006

Last Update Submit

April 12, 2011

Conditions

Pain

Keywords

Pain Response

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States

  • Samples taken at baseline and recovery;Salivary Cortisol sample

Interventions

breastfeedingPROCEDURE

See detailed description.

Eligibility Criteria

Age3 Days+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's and Women's Health Centre of British Columbia, Special Care Nursery

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Lactation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Liisa Holsti, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

CA(1)