Breast Feeding Analgesia in Preterm Infants

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

Detailed Description
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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.

Official Title
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Breast Feeding Analgesia in Preterm Infants

Conditions
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Pain

Intervention / Treatment
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* Procedure: Blood collection
* Procedure: Blood collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Procedure: Blood collection<br>* 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.<br>|
| Active Comparator: 2<br>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. | Procedure: Blood collection<br>* For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videotaped and recorded at Baseline, Lance and Recovery: |  |  | 
| Behavioral Indicators of Infant Pain (BIIP) - total score |  |  | 
| Heart Rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videotaped and Recorded at Baseline, Lance and Recovery: |  |  | 
| Hand Movements |  |  | 
| Sleep/Wake States |  |  | 
| Samples taken at baseline, lance and recovery |  |  | 
| Salivary Cortisol sample |  |  | 
| Recorded before the breast feeding intervention and at 24 hours following: |  |  | 
| Preterm Infant Breastfeeding Behavior Scale |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Response