Breast Feeding Analgesia in Preterm Infants

University of British Columbia

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Procedure: Blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT00175409

C05-0248

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 days to 37 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood collection

Procedure: Blood collection

2

Active Comparator group

Description:

Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Treatment:

Procedure: Blood collection

Procedure: Blood collection