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The Holding Study: Feeding Analgesia in Preterm Infants

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

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


  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States [ Time Frame: Unspecified ]
  • Samples taken at baseline and recovery;Salivary Cortisol sample [ Time Frame: Unspecified ]

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00414258

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
Principal Investigator: Liisa Holsti, Ph.D University of British Columbia
  More Information

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

Keywords provided by University of British Columbia:
Pain Response processed this record on August 21, 2017