Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

Breastfeeding Clinical Trial

Official title:

Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03709004
• Other study ID #: 1132743
• Status: Withdrawn
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: September 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Other:
• Pacifier
Pacifier given to mom.

Locations

Country	Name	City	State
United States	University of California Medical Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Benedictine University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Stress	Via Perceived Stress Scale (10 items, 5-point Likert scale)	2, 4, 6, 12, 18, and 24 weeks
Other	Infant Feeding Efficiency	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	2 and 6 weeks
Primary	Infant Feeding - Breastfeeding Status	Mode of infant feeding: yes or no	up to 24 weeks
Primary	Infant Feeding - Breastfeeding Duration	Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)	up to 24 weeks
Secondary	Pacifier Use	Any use and frequency in the last 24 hours (7-point Likert scale)	2, 4, and 6 weeks