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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitative Intervention | Experimental | Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes. |
|
| Control Intervention | Active Comparator | Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitative | Other | Non-nutritive sucking on emptied breast |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University | Kingston | Ontario | K7L2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33714801 | Derived | Fucile S, Wener E, Dow K. Enhancing breastfeeding establishment in preterm infants: A randomized clinical trial of two non-nutritive sucking approaches. Early Hum Dev. 2021 May;156:105347. doi: 10.1016/j.earlhumdev.2021.105347. Epub 2021 Mar 10. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
| Active Comparator |
| Other |
Non-nutritive sucking on pacifier |
|
Number of infants receiving direct breastfeeding 6 months after hospital discharge
| Through study completion, an average of 2 years |
| D000091642 | Urogenital Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |