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Completed

NCT Number: NCT00414258

The Holding Study: Feeding Analgesia in Preterm Infants

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's and Women's Health Centre of British Columbia, Special Care Nursery

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding

Procedure

See detailed description.

Primary outcomes

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

Secondary outcomes

  1. Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States

  2. Samples taken at baseline and recovery;Salivary Cortisol sample

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 21, 2006
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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