Non-nutritive Sucking and Breastfeeding in Preterm Infants

Study Overview
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Brief Summary
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The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.

Detailed Description
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Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants. The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.

Official Title
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Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely

Conditions
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Infant,Premature, Infant Development, Infant, Very Low Birth Weight

Intervention / Treatment
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* Other: Rehabilitative
* Other: Active Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: born less than or equal to 34 weeks gestational age (GA); appropriate size for their GA; receiving nasal continuous positive airway pressure; receiving only enteral feedings (orogastric or nasogastric); mothers are pumping their milk. Exclusion Criteria: congenital anomalies mother not expressing milk transferred in hospital

Ages Eligible for Study
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Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitative Intervention<br>Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes. | Other: Rehabilitative<br>* Non-nutritive sucking on emptied breast<br>|
| Active Comparator: Control Intervention<br>Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes. | Other: Active Comparator<br>* Non-nutritive sucking on pacifier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to transition from full tube to full oral feeds | Number of days to transition from full tube to full oral (bottle/breast) feedings | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding acquisition at hospital discharge | Number of infants receive greater than 50% of direct breastfeeding at hospital discharge | Through study completion, an average of 2 years | 
| Breastfeeding duration | Number of infants receiving direct breastfeeding 6 months after hospital discharge | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral feeding, early intervention, premature infant, sucking