Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Number of days to transition from full tube to full oral feeds
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
Eligibility Criteria
- Ages
- — to 35 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rehabilitative Intervention
Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.
Intervention: Rehabilitative (Other)
Control Intervention
Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.
Intervention: Active Comparator (Other)
Outcomes
Primary Outcomes
Number of days to transition from full tube to full oral feeds
Time Frame: Through study completion, an average of 2 years
Number of days to transition from full tube to full oral (bottle/breast) feedings
Secondary Outcomes
- Breastfeeding acquisition at hospital discharge(Through study completion, an average of 2 years)
- Breastfeeding duration(Through study completion, an average of 2 years)
Investigators
Dr. Sandra Fucile
Assistant Professor-adjunct
Queen's University