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The Holding Study: Feeding Analgesia in Preterm Infants

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ClinicalTrials.gov Identifier: NCT00414258
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Procedure: breastfeeding Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Holding Pilot Study: Feeding Analgesia in Preterm Infants
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Intervention Details:
    Procedure: breastfeeding
    See detailed description.


Primary Outcome Measures :
  1. Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate

Secondary Outcome Measures :
  1. Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
  2. Samples taken at baseline and recovery;Salivary Cortisol sample


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Liisa Holsti, University of British Columbia
ClinicalTrials.gov Identifier: NCT00414258     History of Changes
Other Study ID Numbers: C06 - 0347
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by University of British Columbia:
Pain Response