Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

NCT03709004 — Not applicable, Withdrawn, University of California, Davis

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

Registry	NCT03709004
Status	Withdrawn - This study was not funded and is not going to be done.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Sponsor	University of California, Davis (Other); collaborators: Benedictine University, Yale University
Conditions	Breastfeeding, Postpartum Depression
Interventions	Pacifier (Other)
Dates	start 2019-09-25, primary completion 2019-09-25, completion 2019-09-25, first posted 2018-10-17, last updated 2019-09-27
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Pacifier	Experimental	Other: Pacifier	Mother given a pacifier during birth hospitalization, along with other baby items
Control	No intervention		Mother not given a pacifier, just the other baby items

Pacifier (Other): Pacifier given to mom.

+Outcome measures

Primary outcomes

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 outcomes

Pacifier Use [2, 4, and 6 weeks]: Any use and frequency in the last 24 hours (7-point Likert scale)

Other outcomes

Maternal Stress [2, 4, 6, 12, 18, and 24 weeks]: Via Perceived Stress Scale (10 items, 5-point Likert scale)
Infant Feeding Efficiency [2 and 6 weeks]: 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

+Eligibility

Sex: All, ages: 12 Hours to 45 Years

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

+Locations (1)

Facility	City	Country	Status
University of California Medical Center	Sacramento, California	United States

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