Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

NCT03709004 | Withdrawn DMC

• 1 other identifier: 1132743
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Postpartum Depression

Keywords

Pacifier

Outcome Measures

Primary Outcomes (2)

• Infant Feeding - Breastfeeding Status

  Mode of infant feeding: yes or no

  up to 24 weeks

• Infant Feeding - Breastfeeding Duration

  Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)

  up to 24 weeks

Secondary Outcomes (1)

• Pacifier Use

  2, 4, and 6 weeks

Other Outcomes (2)

• Maternal Stress

  2, 4, 6, 12, 18, and 24 weeks

• Infant Feeding Efficiency

  2 and 6 weeks

Study Arms (2)

Pacifier

EXPERIMENTAL

Mother given a pacifier during birth hospitalization, along with other baby items

Other: Pacifier

Control

NO INTERVENTION

Mother not given a pacifier, just the other baby items

Interventions

Pacifier OTHER

Pacifier given to mom.

Pacifier

Eligibility Criteria

• Age: 12 Hours - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Benedictine University: collaborator
• Yale University: collaborator

Study Sites (1)

University of California Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum

Interventions

Pacifiers

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: October 17, 2018
• Study Start: September 25, 2019
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)