Sudden Infant DeathPhase 3NCT00306956
Influence of Pacifiers on Breastfeeding Duration
A Phase 3 study testing offer a pacifier in people with Sudden Infant Death, run by Fundacion para la Salud Materno Infantil at 5 sites in Argentina.
Trial summary
The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings. Read more about this study
- Who is it for?
- Ages 14 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death
- What is being tested?
- offer a pacifier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- 5 sitesArgentina
- Study dates
- Mar 2006to May 2008
- Phase
- Phase 3
- 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 14 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The following patients will be invited to participate before hospital discharge:
- Women who agree not to introduce the pacifier before 2 weeks
- Intention to exclusively breastfeed their infants for at least 3 months
- Breastfeeding exclusively at discharge
- Delivered a healthy singleton newborn
- 37 completed weeks and at least a 2.5 kg birth weight
Show all 13Show fewer
- Possibility of contact by telephone
- Patients will be randomized at age 15 days if:
- They are exclusively breastfeeding
- They have no existing breastfeeding problems
- Babies use no pacifiers.
- Breastfeeding is well established
- No maternal risk factors for lactation problems
Who cannot join
- Extremely or persistently sore nipples
- Presence of mastitis or abscess formation.
- Medical situations contraindicating breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Argentina5 sites
Hospital Privado del Sur
Bahía Blanca, Buenos Aires, 8000
Hospital Italiano de Buenos Aires
Buenos Aires, 1181ACH
Sanatorio de la Trinidad
Buenos Aires, 1425
Hospital Diego Paroissien
Isidro Casanova, Buenos Aires, 1765
Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"
San Isidro, Buenos Aires
About this study
Official title: Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial
The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.
Read the detailed description
The incidence of Sudden infant death syndrome in developing countries is comparable with that of developed countries. Two important risk factors with implications for prevention are prone sleeping position and the association with smoke. Also, breastfeeding has been reported to be protective against SIDS.
In accordance with WHO/UNICEF recommendations, lactation consultants and other health professionals within "Baby-Friendly" institutions typically discourage the use of pacifiers in breastfed infants. The recent American Academy of Pediatrics policy statement, however, recommends pacifier use, during periods of sleep as a potential method to reduce the risk of SIDS. Previous observational studies had been unanimous in reporting an approximate doubling of the risk of early weaning with daily pacifier use. However, randomized controlled trials in developed countries, have not shown that giving pacifiers results in shorter breastfeeding duration, except when pacifiers are given in the first 5 days. It has therefore been seen that practically every author of a major study on the association between breastfeeding and pacifier use has proposed that the question can only be fully and completely answered by randomized studies. To date there are no large randomized studies evaluating the influence of pacifier use on breastfeeding duration.
Our Primary outcome is to compare the prevalence of exclusive breastfeeding at three months in infants between groups randomised to pacifier and no pacifier exposure once breastfeedings have been fully established.
Second outcome: to evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding.
Recruitment to the trial will take place in several public and private hospitals.
Those mothers who do not show a strong preference in regards to the introduction of the pacifier, will be randomised during the postpartum visit at 2 weeks (if well established breastfeeding is present) on two arms:
- No pacifier,
- Pacifier introduced at 15 days.
Structured telephone interviews will be conducted at 1, 2, 3, 4, 5, and 6 months and every 60 days thereafter until the breastfeeding has ended to record breastfeeding duration and type (exclusive or not) and pacifier use.
- Conditions
- Sudden Infant Death
- Being tested
- offer a pacifier
- Keywords
- Infant, Newborn, pacifier, dummies, breastfeeding, Sudden Infant Death, SIDS, Pacifiers
- Medical subject headings
- Sudden Infant Death, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
offer a pacifierBehavioural
To offer a pacifier to normal newborn infants at 15 days of age
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding Receives: Behavioral: offer a pacifier |
| B | Active comparator | Recommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age Receives: Behavioral: offer a pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established.
Measured: Three months
Secondary outcomes (4)
To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding
Measured: one year
To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use
Measured: one year
To test whether pacifier use is causally related with muguet, otitis and sore nipples
Measured: one year
Compliance with group assignment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant DeathStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Salud Materno Infantil
- Sponsor type
- University, hospital or other
- Collaborators
- International Childrens Medical Research Association, Switzerland.
- Investigators
- Alejandro Jenik, M.D., Principal investigator, Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306956
- Sponsor's protocol ID
- FUNDASAMIN101
- Status last verified
- Sep 2008
- First submitted
- 23 Mar 2006
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00306956
- Acronym / sponsor ID
- FUNDASAMIN101
- Conditions
- Sudden Infant Death
- Keywords
- Infant, Newborn, pacifier, dummies, breastfeeding, Sudden Infant Death, SIDS, Pacifiers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Fundacion para la Salud Materno InfantilUniversity, hospital or other
- Collaborators
- International Childrens Medical Research Association, Switzerland.
- Study start
- Mar 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Mar 2006 (estimated)
- 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.
The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.
Detailed description
The incidence of Sudden infant death syndrome in developing countries is comparable with that of developed countries. Two important risk factors with implications for prevention are prone sleeping position and the association with smoke. Also, breastfeeding has been reported to be protective against SIDS.
In accordance with WHO/UNICEF recommendations, lactation consultants and other health professionals within "Baby-Friendly" institutions typically discourage the use of pacifiers in breastfed infants. The recent American Academy of Pediatrics policy statement, however, recommends pacifier use, during periods of sleep as a potential method to reduce the risk of SIDS. Previous observational studies had been unanimous in reporting an approximate doubling of the risk of early weaning with daily pacifier use. However, randomized controlled trials in developed countries, have not shown that giving pacifiers results in shorter breastfeeding duration, except when pacifiers are given in the first 5 days. It has therefore been seen that practically every author of a major study on the association between breastfeeding and pacifier use has proposed that the question can only be fully and completely answered by randomized studies. To date there are no large randomized studies evaluating the influence of pacifier use on breastfeeding duration.
Our Primary outcome is to compare the prevalence of exclusive breastfeeding at three months in infants between groups randomised to pacifier and no pacifier exposure once breastfeedings have been fully established.
Second outcome: to evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding.
Recruitment to the trial will take place in several public and private hospitals.
Those mothers who do not show a strong preference in regards to the introduction of the pacifier, will be randomised during the postpartum visit at 2 weeks (if well established breastfeeding is present) on two arms:
- No pacifier,
- Pacifier introduced at 15 days.
Structured telephone interviews will be conducted at 1, 2, 3, 4, 5, and 6 months and every 60 days thereafter until the breastfeeding has ended to record breastfeeding duration and type (exclusive or not) and pacifier use.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: offer a pacifierRecommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding |
| B | Active comparator | Behavioral: offer a pacifierRecommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age |
Who may qualify
- Ages
- 14 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Women who agree not to introduce the pacifier before 2 weeks
- Intention to exclusively breastfeed their infants for at least 3 months
- Breastfeeding exclusively at discharge
- Delivered a healthy singleton newborn
- 37 completed weeks and at least a 2.5 kg birth weight
Key exclusion criteria (3 listed)
- Extremely or persistently sore nipples
- Presence of mastitis or abscess formation.
- Medical situations contraindicating breastfeeding
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 pacifierTo offer a pacifier to normal newborn infants at 15 days of age | Behavioural | A, B |
Primary outcome
The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established.
Time frame: Three months
4 secondary outcomes
To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding
Time frame: one year
To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use
Time frame: one year
To test whether pacifier use is causally related with muguet, otitis and sore nipples
Time frame: one year
Compliance with group assignment
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
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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 Jenik, M.D. principal investigator
Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing offer a pacifier in people with Sudden Infant Death, run by Fundacion para la Salud Materno Infantil at 5 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 13 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established. (time frame: Three months). 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 19 Sep 2008.