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Completed

NCT Number: NCT00175409

Breast Feeding Analgesia in Preterm Infants

The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier. 2. Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

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Key information

Conditions

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

Age range

3 day–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lions Gate Hospital - Special Care Nursery, North Vancouver, British Columbia, Canada

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About this study

Research Method:

In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate 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 feeding condition, infants will be held and then breast fed by their mother 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 30-36 weeks gestational age
  • breastfeeding
  • mother has fluent English

Exclusion criteria

  • CNS injury
  • congenital anomaly
  • active infection
  • has had surgeries or analgesics/sedatives in last 72 hours
  • history of maternal drug exposure

Treatment and study plan

Blood Collection

Procedure

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.

Primary outcomes

  1. Videotaped and recorded at Baseline, Lance and Recovery:

  2. Behavioral Indicators of Infant Pain (BIIP) - total score

  3. Heart Rate

Secondary outcomes

  1. Videotaped and Recorded at Baseline, Lance and Recovery:

  2. Hand Movements

  3. Sleep/Wake States

  4. Samples taken at baseline, lance and recovery

  5. Salivary Cortisol sample

  6. Recorded before the breast feeding intervention and at 24 hours following:

  7. Preterm Infant Breastfeeding Behavior Scale

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • SickKids Foundation

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2005
Registry last updated
Apr 12, 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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