Infant Development, Infant,Premature, Infant, Very Low Birth Weight
Conditions
Keywords
oral feeding, early intervention, premature infant, sucking
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.
Interventions
OTHERRehabilitative
Non-nutritive sucking on emptied breast
OTHERActive Comparator
Non-nutritive sucking on pacifier
Sponsors
Dr. Sandra Fucile
Study design
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
Sex/Gender
ALL
Age
No minimum to 35 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days to transition from full tube to full oral feeds | Through study completion, an average of 2 years | Number of days to transition from full tube to full oral (bottle/breast) feedings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding acquisition at hospital discharge | Through study completion, an average of 2 years | Number of infants receive greater than 50% of direct breastfeeding at hospital discharge |
| Breastfeeding duration | Through study completion, an average of 2 years | Number of infants receiving direct breastfeeding 6 months after hospital discharge |
Countries
Canada
Outcome results
None listed