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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03709004
Other study ID # 1132743
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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