The Holding Study: Feeding Analgesia in Preterm Infants - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00414258

Purpose

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:

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

Condition	Intervention
Pain	Procedure: breastfeeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Samples taken at baseline and recovery;Salivary Cortisol sample [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

See detailed description.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414258

Contacts

Contact: Colleen Jantzen

604-875-2000 ext 5995

cjantzen@cw.bc.ca

Locations

Canada, British Columbia
Children's and Women's Health Centre of British Columbia, Special Care Nursery	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Colleen Jantzen, BA 604-875-2000 ext 5995 cjantzen@cw.bc.ca
Principal Investigator: Linda Holsti

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Liisa Holsti, Ph.D

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Liisa Holsti )
Study ID Numbers:	C06 - 0347
Study First Received:	December 19, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00414258
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Pain Response

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009