Back to resultsPacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
Primary Purpose
Breastfeeding, Postpartum Depression
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacifier
Sponsored by
About this trial
This is an interventional supportive care trial for Breastfeeding focused on measuring Pacifier
Eligibility Criteria
Inclusion Criteria:
- Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age
Exclusion Criteria:
- infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone
Sites / Locations
- University of California Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pacifier
Control
Arm Description
Mother given a pacifier during birth hospitalization, along with other baby items
Mother not given a pacifier, just the other baby items
Outcomes
Primary Outcome Measures
Infant Feeding - Breastfeeding Status
Mode of infant feeding: yes or no
Infant Feeding - Breastfeeding Duration
Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)
Secondary Outcome Measures
Pacifier Use
Any use and frequency in the last 24 hours (7-point Likert scale)
Full Information
NCT ID
NCT03709004
First Posted
July 17, 2018
Last Updated
September 25, 2019
Sponsor
University of California, Davis
Collaborators
Benedictine University, Yale University
1. Study Identification
Unique Protocol Identification Number
NCT03709004
Brief Title
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
Official Title
Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
This study was not funded and is not going to be done.
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Benedictine University, Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We will enroll 40 mother-infant dyads in a randomized trial exploring the effect of distribution of pacifiers during the birth hospitalization to mothers at high risk for postpartum depression on pacifier use, infant feeding, and maternal stress.
Detailed Description
This study is a pilot a randomized controlled trial to determine if pacifier distribution affects breastfeeding among mothers at high risk for postpartum depression. We will recruit 40 mothers of healthy singleton births in a U.S. hospital who are at high risk of postpartum depression and randomly assign them to receive a pacifier or not. We will ascertain pacifier use, maternal stress, and infant feeding behaviors with web-based surveys at 2, 4, 6, 12, 18, and 24 weeks. Mothers will also wear a wristband to detect maternal heart rate variability throughout the first 6 weeks as a marker of maternal stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Postpartum Depression
Keywords
Pacifier
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacifier
Arm Type
Experimental
Arm Description
Mother given a pacifier during birth hospitalization, along with other baby items
Arm Title
Control
Arm Type
No Intervention
Arm Description
Mother not given a pacifier, just the other baby items
Intervention Type
Other
Intervention Name(s)
Pacifier
Intervention Description
Pacifier given to mom.
Primary Outcome Measure Information:
Title
Infant Feeding - Breastfeeding Status
Description
Mode of infant feeding: yes or no
Time Frame
up to 24 weeks
Title
Infant Feeding - Breastfeeding Duration
Description
Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Pacifier Use
Description
Any use and frequency in the last 24 hours (7-point Likert scale)
Time Frame
2, 4, and 6 weeks
Other Pre-specified Outcome Measures:
Title
Maternal Stress
Description
Via Perceived Stress Scale (10 items, 5-point Likert scale)
Time Frame
2, 4, 6, 12, 18, and 24 weeks
Title
Infant Feeding Efficiency
Description
Volume of breast milk or formula consumed via bottle within the first three minutes of feeding (mL/min); considered in the context of the infants' state (e.g., alert/awake, drowsy) and nipple size
Time Frame
2 and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age
Exclusion Criteria:
infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone
Facility Information:
Facility Name
University of California Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
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