LactationNCT03981133
Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration
A study testing offer a pacifier and no pacifier in people with Lactation, run by Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal at 6 sites in Argentina.
Trial summary
We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. . Read more about this study
- Who is it for?
- Ages 6 hours to 3 days
- Conditions the study is for
- Lactation
- What is being tested?
- offer a pacifier and no pacifier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 6 sitesArgentina
- Study dates
- Jan 2020to Dec 2022
- 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 6 hours to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
- Expressed an intention to breast feed exclusively their infant for at least 3 -months
- Possibility of contact by telephone
- Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
- Primiparous single birth
- Mother´s age 18 years or more
Who cannot join
- Maternal risk factors for lactation
- Lack of noticeable breast enlargement during pregnancy
- Flat or inverted nipples
- Variation in breast appearance (marked asymmetry, hypoplastic, tubular)
- Any previous breast surgery, including plastics procedure
- Psychosocial problems (eg, depression, poor or negative support of breastfeeding
Show all 9Show fewer
- Mother with a chronic condition that could influence development , including feeding ability
- Mother with eating or mental disorder.
- Mothers who smoke during pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Argentina6 sites
Hospital Privado de del Sur
Bahía Blanca, Buenos Aires, 8000
Hospital Italiano de buenos Aires
CABA, Buenos Aires, 1199ABB
Sanatorio de la Trinidad
CABA, Buenos Aires, 1425
Alejandro Jenik
Olivos, Buenos Aires, 1636
Alejandro G Jenik, M.D., 5491144061380, alejandro.jenik@hiba.org.ar
Alejandro G Jenik, M.D, 5491144061389
Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t
San Isidro, Buenos Aires
Centro Agustin Rocca HIBA
San Justo, Buenos Aires, B1702
About this study
Official title: The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial
We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .
Read the detailed description
Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation
A research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:
Unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.
- Conditions
- Lactation
- Being tested
- offer a pacifier, no pacifier
- Keywords
- pacifier, breastfeeding, sudden unexpected infant death
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
offer a pacifierBehavioural
offer a pacifier to normal newborn infants the first days of life
no pacifierBehavioural
not to offer a pacifier at 15 days of life
| Study group | Role | What they receive |
|---|---|---|
| A: unrestricted pacifier | Experimental | recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life Receives: Behavioral: offer a pacifier |
| restricted pacifierr | Active comparator | recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live Receives: Behavioral: no pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of exclusive breastfeeding
To compare the prevalence of exclusive breastfeeding at three, four and six months in infants between groups randomized to unrestricted pacifier group and restricted pacifier group
Measured: up to 24 weeks
Secondary outcomes (1)
infant feeding - breastfeeding duration
to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, Fundacion para la Salud Materno Infantil
- Responsible party
- Principal investigator, Alejandro Jenik, Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
- Investigators
- alejandro G Jenik, MD, Principal investigator, Fundacion para el Estudio y la Prevencion de la Muerte Infantil y PerinatalAleajndro G Jenik, MD, Principal investigator, Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981133
- Sponsor's protocol ID
- marita909
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial
- ClinicalTrials.gov ID
- NCT03981133
- Acronym / sponsor ID
- marita909
- Conditions
- Lactation
- Keywords
- pacifier, breastfeeding, sudden unexpected infant death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Fundación para el Estudio y Prevención de la Muerte Infantil y PerinatalUniversity, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, Fundacion para la Salud Materno Infantil
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jun 2019 (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 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .
Detailed description
Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation
A research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:
Unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: unrestricted pacifier | Experimental | Behavioral: offer a pacifierrecommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life |
| restricted pacifierr | Active comparator | Behavioral: no pacifierrecommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live |
Who may qualify
- Ages
- 6 hours to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
- Expressed an intention to breast feed exclusively their infant for at least 3 -months
- Possibility of contact by telephone
- Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
- Primiparous single birth
Key exclusion criteria (9 listed)
- Maternal risk factors for lactation
- Psychosocial problems (eg, depression, poor or negative support of breastfeeding
- Mother with a chronic condition that could influence development , including feeding ability
- Mother with eating or mental disorder.
- Mothers who smoke during pregnancy
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 |
|---|---|---|
| offer a pacifieroffer a pacifier to normal newborn infants the first days of life | Behavioural | A: unrestricted pacifier |
| no pacifiernot to offer a pacifier at 15 days of life | Behavioural | restricted pacifierr |
Primary outcome
Prevalence of exclusive breastfeeding
Time frame: up to 24 weeks
To compare the prevalence of exclusive breastfeeding at three, four and six months in infants between groups randomized to unrestricted pacifier group and restricted pacifier group
1 secondary outcome
infant feeding - breastfeeding duration
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: Yes. weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin
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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.
alejandro G Jenik, MD principal investigator
Fundacion para el Estudio y la Prevencion de la Muerte Infantil y Perinatal
Aleajndro G Jenik, MD principal investigator
Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing offer a pacifier and no pacifier in people with Lactation, run by Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal at 6 sites in Argentina.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro G Jenik (5491144061380, alejandro.jenik@hiba.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of exclusive breastfeeding (time frame: up to 24 weeks). 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 10 Jun 2019.