Back to resultsNon-nutritive Sucking and Breastfeeding in Preterm Infants
Primary Purpose
Infant,Premature, Infant Development, Infant, Very Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rehabilitative
Active Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Infant,Premature focused on measuring oral feeding, early intervention, premature infant, sucking
Eligibility Criteria
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
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitative Intervention
Control Intervention
Arm Description
Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.
Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Breastfeeding acquisition at hospital discharge
Number of infants receive greater than 50% of direct breastfeeding at hospital discharge
Breastfeeding duration
Number of infants receiving direct breastfeeding 6 months after hospital discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03434743
Brief Title
Non-nutritive Sucking and Breastfeeding in Preterm Infants
Official Title
Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Sandra Fucile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant,Premature, Infant Development, Infant, Very Low Birth Weight
Keywords
oral feeding, early intervention, premature infant, sucking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitative Intervention
Arm Type
Experimental
Arm Description
Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.
Arm Title
Control Intervention
Arm Type
Active Comparator
Arm Description
Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.
Intervention Type
Other
Intervention Name(s)
Rehabilitative
Intervention Description
Non-nutritive sucking on emptied breast
Intervention Type
Other
Intervention Name(s)
Active Comparator
Intervention Description
Non-nutritive sucking on pacifier
Primary Outcome Measure Information:
Title
Number of days to transition from full tube to full oral feeds
Description
Number of days to transition from full tube to full oral (bottle/breast) feedings
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Breastfeeding acquisition at hospital discharge
Description
Number of infants receive greater than 50% of direct breastfeeding at hospital discharge
Time Frame
Through study completion, an average of 2 years
Title
Breastfeeding duration
Description
Number of infants receiving direct breastfeeding 6 months after hospital discharge
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33714801
Citation
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.
Results Reference
derived
Learn more about this trial
Non-nutritive Sucking and Breastfeeding in Preterm Infants
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