BreastfeedingNCT03709004
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
A study testing Pacifier in people with Breastfeeding and Postpartum Depression, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 hours to 45 years
- Conditions the study is for
- Breastfeeding, Postpartum Depression
- What is being tested?
- Pacifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 hours to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center
Sacramento, California, 95817
About this study
Official title: Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression
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.
Read the 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.
- Conditions
- Breastfeeding, Postpartum Depression
- Being tested
- Pacifier
- Keywords
- Pacifier
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacifierOther
Pacifier given to mom.
| Study group | Role | What they receive |
|---|---|---|
| Pacifier | Experimental | Mother given a pacifier during birth hospitalization, along with other baby items Receives: Other: Pacifier |
| Control | No intervention | Mother not given a pacifier, just the other baby items |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Feeding - Breastfeeding Status
Mode of infant feeding: yes or no
Measured: up to 24 weeks
Infant Feeding - Breastfeeding Duration
Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)
Measured: up to 24 weeks
Secondary outcomes (1)
Pacifier Use
Any use and frequency in the last 24 hours (7-point Likert scale)
Measured: 2, 4, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start25 Sep 2019
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Why it stopped: This study was not funded and is not going to be done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Benedictine University, Yale University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709004
- Sponsor's protocol ID
- 1132743
- Status last verified
- Sep 2019
- First submitted
- 17 Jul 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression
- ClinicalTrials.gov ID
- NCT03709004
- Acronym / sponsor ID
- 1132743
- Conditions
- Breastfeeding, Postpartum Depression
- Keywords
- Pacifier
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not funded and is not going to be done.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Benedictine University, Yale University
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacifier | Experimental | Other: PacifierMother given a pacifier during birth hospitalization, along with other baby items |
| Control | No intervention | –Mother not given a pacifier, just the other baby items |
Who may qualify
- Ages
- 12 hours to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacifierPacifier given to mom. | Other | Pacifier |
Primary outcome
Infant Feeding - Breastfeeding Status
Time frame: up to 24 weeks
Mode of infant feeding: yes or no
Infant Feeding - Breastfeeding Duration
Time frame: up to 24 weeks
Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)
1 secondary outcome
Pacifier Use
Time frame: 2, 4, and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacifier in people with Breastfeeding and Postpartum Depression, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Feeding - Breastfeeding Status (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.