Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

Not Applicable

Withdrawn

• Conditions: Breastfeeding; Postpartum Depression
• Interventions: Other: Pacifier

• Registration Number: NCT03709004
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Status Verified: 2019-09
• Study Start: 2019-09-25
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pacifier	Pacifier	Mother given a pacifier during birth hospitalization, along with other baby items

Primary Outcome Measures

Name	Time	Method
Infant Feeding - Breastfeeding Status	up to 24 weeks	Mode of infant feeding: yes or no
Infant Feeding - Breastfeeding Duration	up to 24 weeks	Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)

Secondary Outcome Measures

Name	Time	Method
Pacifier Use	2, 4, and 6 weeks	Any use and frequency in the last 24 hours (7-point Likert scale)

Trial Locations

Locations (1)

University of California Medical Center; 🇺🇸 Sacramento, California, United States