The Holding Study: Feeding Analgesia in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00414258
First received: December 19, 2006
Last updated: April 12, 2011
Last verified: April 2011
  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:

  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.

Condition Intervention
Pain
Procedure: breastfeeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Resource links provided by NLM:


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 ]

Enrollment: 15
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breastfeeding
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, British Columbia
Children's and Women's Health Centre of British Columbia, Special Care Nursery
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Liisa Holsti, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Liisa Holsti, University of British Columbia
ClinicalTrials.gov Identifier: NCT00414258     History of Changes
Other Study ID Numbers: C06 - 0347
Study First Received: December 19, 2006
Last Updated: April 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Pain Response

ClinicalTrials.gov processed this record on August 20, 2014