Non-nutritive Sucking and Breastfeeding in Preterm Infants
Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2017
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedOctober 1, 2020
September 1, 2020
1.9 years
January 29, 2018
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Breastfeeding acquisition at hospital discharge
Through study completion, an average of 2 years
Breastfeeding duration
Through study completion, an average of 2 years
Study Arms (2)
Rehabilitative Intervention
EXPERIMENTALExperimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.
Control Intervention
ACTIVE COMPARATORControl active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- congenital anomalies
- mother not expressing milk
- transferred in hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen's University
Kingston, Ontario, K7L2V7, Canada
Related Publications (1)
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.
PMID: 33714801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor-adjunct
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 15, 2018
Study Start
July 28, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share