ClinicalTrials.Veeva

Menu

The Holding Study: Feeding Analgesia in Preterm Infants

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

Pain

Treatments

Procedure: breastfeeding

Study type

Interventional

Funder types

Other

Identifiers

NCT00414258
C06 - 0347

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

3+ days old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems