PacifierNCT06889441
Pacifier Use and Infant Development
An observational study of Pacifier and Infant Development, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Pacifier use reduces the risk of sudden infant death syndrome, and nonnutritive sucking has been shown to improve physiological balance and feeding in premature infants. Therefore, the risks and benefits of pacifier use should be carefully considered. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Pacifier, Infant Development, Sensory Processing Disorder
- What is being tested?
- Test of sensory function in infants, The Peabody Developmental Motor Scales-Second Edition and Infant/toddler sensory profile
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2025to 1 Jun 2025
- Phase
- Observational
- 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 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full-term infants who have used a pacifier for at least 6 months and full-term infants who have never used a pacifier will be included in the study. The motor and sensory development of the included children will be compared according to their pacifier use status.
Who may be able to join
- Full-term infants who have used a pacifier for at least 6 months and are still using it,
- Babies who do not have sucking dysfunction and are breastfed for the first 6 months,
- Post-term infants who are between 9-12 months old
Who cannot join
- Premature infants
- Infants with congenital malformations
- Infants diagnosed with metabolic, neurological and genetic diseases
- Children whose parents do not volunteer for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pacifier Use on Motor Development and Sensory Processing Skills in Infants
Pacifier use reduces the risk of sudden infant death syndrome, and nonnutritive sucking has been shown to improve physiological balance and feeding in premature infants. Therefore, the risks and benefits of pacifier use should be carefully considered. In a study, it was reported that giving a pacifier on the 15th day did not change the prevalence and duration of breastfeeding, that using a pacifier was associated with a lower incidence of sudden infant death syndrome, and that giving a pacifier was a useful approach. Using a pacifier can help the baby calm down and adapt to the environment. When the literature was reviewed, conflicting results were reported regarding using a pacifier. However, the effect of using a pacifier on the baby's motor development and especially sensory processing skills has not been clearly investigated.
Read the detailed description
Pacifier use is a very common practice. It is often used in the early years of a child's life to help them fall asleep or to soothe and calm them down from teething pain. The age at which a pacifier is discontinued is usually around the age of three when the child goes to nursery. Observational studies have linked early pacifier use with breastfeeding problems leading to early weaning. However, randomized controlled trials have not shown a similar negative association between early pacifier use and successful breastfeeding, suggesting that pacifier use may be a sign of breastfeeding problems and not the cause. Pacifier use is often a topic of debate when parents and professionals aim to maintain and support breastfeeding. However, the literature supports the beneficial effects of pacifier use in infants because of the associated physiological benefits, such as digestion, behavioral organization, pain management, motor function, and sucking development.
Pacifier use reduces the risk of sudden infant death syndrome, and nonnutritive sucking has been shown to improve physiological balance and feeding in premature infants. Therefore, the risks and benefits of pacifier use should be carefully considered. In a study, it was reported that giving a pacifier on the 15th day did not change the prevalence and duration of breastfeeding, that using a pacifier was associated with a lower incidence of sudden infant death syndrome, and that giving a pacifier was a useful approach. Using a pacifier can help the baby calm down and adapt to the environment. When the literature was reviewed, conflicting results were reported regarding using a pacifier. However, the effect of using a pacifier on the baby's motor development and especially sensory processing skills has not been clearly investigated. The aim of this study was to evaluate babies using a pacifier in terms of both motor development and sensory processing skills and to compare them with their peers who did not use a pacifier.
- Conditions
- Pacifier, Infant Development, Sensory Processing Disorder
- Being tested
- Test of sensory function in infants, The Peabody Developmental Motor Scales-Second Edition, Infant/toddler sensory profile
- Keywords
- Pacifier use, development, Sensory Processing Skills, motor development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of sensory function in infantsBehavioural
It was planned to use the Test of sensory function in infants to evaluate the sensory development of infants. The test of sensory function in infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The test of sensory function in infants requires the infant to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has normative values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months.
The Peabody Developmental Motor Scales-Second EditionBehavioural
The Peabody Developmental Motor Scales-Second Edition is a standardized, norm-referenced assessment instrument designed to evaluate both gross and fine motor skills in children aged 0 to 71 months. It is frequently employed in clinical, educational, and research contexts to detect motor developmental delays, monitor developmental trajectories, and inform intervention strategies. Notably, higher scores on the scale reflect superior motor performance, indicating better developmental outcomes
Infant/toddler sensory profileBehavioural
The infant/toddler sensory profile is a questionnaire filled out by the child's primary caregiver to collect information about sensory processing abilities. The test evaluates sensory processing in 6 different areas. These items consist of general, visual, auditory, vestibular, tactile and oral sensory processing. The caregiver evaluates the child's behavior on a 5-point scale. One point means "almost always" and five points means "almost never". The caregiver's responses are summarized using standard scoring procedures and then interpreted in terms of the impact of a child's sensory processing abilities on the child and their family's lives. The scores are normative for age and are important in assessing sensory development.
| Study group | Role | What they receive |
|---|---|---|
| pacifier user | Full-term infants who have used a pacifier for at least 6 months will be included in the study. The infants' motor development and sensory processing skills will be evaluated. Receives: Behavioral: Test of sensory function in infants; Behavioral: The Peabody Developmental Motor Scales-Second Edition; Behavioral: Infant/toddler sensory profile | |
| non-pacifier | The motor development and sensory processing skills of full-term infants who are 9-12 months old and do not use a pacifier will be evaluated. The developmental results of both groups will be compared Receives: Behavioral: Test of sensory function in infants; Behavioral: The Peabody Developmental Motor Scales-Second Edition; Behavioral: Infant/toddler sensory profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales | Second Edition
The Peabody Developmental Motor Scales-Second Edition is a standardized, norm-referenced assessment instrument designed to evaluate both gross and fine motor skills in children aged 0 to 71 months. The Peabody Developmental Motor Scales-Second Edition comprises six subtests, namely Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, and Visual-Motor Integration, which collectively measure a broad spectrum of motor functions including postural control, locomotor abilities, object manipulation, and hand-eye coordination. The subtests generate three composite scores: the Gross Motor Quotient, Fine Motor Quotient, and Total Motor Quotient, offering a comprehensive evaluation of a child's motor competence. Notably, higher scores on the scale reflect superior motor performance, indicating better developmental outcomes
Measured: 9-12 months
Test of Sensory Functions in Infants
It was planned to use the Test of sensory function in infants to evaluate the sensory development of infants. The test of sensory function in infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The test of sensory function in infants requires the infant to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has normative values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months.
Measured: 9-12 months
Infant/toddler sensory profile
Infant/toddler sensory profile; The infant/toddler sensory profile is a questionnaire filled out by the child's primary caregiver to collect information about sensory processing abilities. It is a questionnaire that questions the behavior and performance of a child between the ages of 0-3 (0-7 months and 7-36 months) regarding sensory processing. The test evaluates sensory processing in 6 different areas. These items consist of general, visual, auditory, vestibular, tactile and oral sensory processing. The caregiver evaluates the child's behavior on a 5-point scale. One point means "almost always" and five points means "almost never". The caregiver's responses are summarized using standard scoring procedures and then interpreted in terms of the impact of a child's sensory processing abilities on the child and their family's lives. The scores are normative for age and are important in assessing sensory development.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start21 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PacifierStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
- Investigators
- Rabia ZORLULAR, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889441
- Sponsor's protocol ID
- pacifier use
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabral TI, Pereira da Silva LG, Tudella E, Simoes Martinez CM. Motor development and sensory processing: A comparative study between preterm and term infants. Res Dev Disabil. 2015 Jan;36C:102-107. doi: 10.1016/j.ridd.2014.09.018. Epub 2014 Oct 16.
PubMed 25462470Dunn, W. and D.B. Daniels, Initial development of the infant/toddler sensory profile. Journal of Early Intervention, 2002. 25(1): p. 27-41.
Howard CR, Howard FM, Lanphear B, Eberly S, deBlieck EA, Oakes D, Lawrence RA. Randomized clinical trial of pacifier use and bottle-feeding or cupfeeding and their effect on breastfeeding. Pediatrics. 2003 Mar;111(3):511-8. doi: 10.1542/peds.111.3.511.
PubMed 12612229Barnes DM, Hanby AM, Gillett CE, Mohammed S, Hodgson S, Bobrow LG, Leigh IM, Purkis T, MacGeoch C, Spurr NK, et al. Abnormal expression of wild type p53 protein in normal cells of a cancer family patient. Lancet. 1992 Aug 1;340(8814):259-63. doi: 10.1016/0140-6736(92)92354-i.
PubMed 1353190
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pacifier Use on Motor Development and Sensory Processing Skills in Infants
- ClinicalTrials.gov ID
- NCT06889441
- Acronym / sponsor ID
- pacifier use
- Conditions
- Pacifier, Infant Development, Sensory Processing Disorder
- Keywords
- Pacifier use, development, Sensory Processing Skills, motor development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Mar 2025 (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.
Pacifier use reduces the risk of sudden infant death syndrome, and nonnutritive sucking has been shown to improve physiological balance and feeding in premature infants. Therefore, the risks and benefits of pacifier use should be carefully considered. In a study, it was reported that giving a pacifier on the 15th day did not change the prevalence and duration of breastfeeding, that using a pacifier was associated with a lower incidence of sudden infant death syndrome, and that giving a pacifier was a useful approach. Using a pacifier can help the baby calm down and adapt to the environment. When the literature was reviewed, conflicting results were reported regarding using a pacifier. However, the effect of using a pacifier on the baby's motor development and especially sensory processing skills has not been clearly investigated.
Detailed description
Pacifier use is a very common practice. It is often used in the early years of a child's life to help them fall asleep or to soothe and calm them down from teething pain. The age at which a pacifier is discontinued is usually around the age of three when the child goes to nursery. Observational studies have linked early pacifier use with breastfeeding problems leading to early weaning. However, randomized controlled trials have not shown a similar negative association between early pacifier use and successful breastfeeding, suggesting that pacifier use may be a sign of breastfeeding problems and not the cause. Pacifier use is often a topic of debate when parents and professionals aim to maintain and support breastfeeding. However, the literature supports the beneficial effects of pacifier use in infants because of the associated physiological benefits, such as digestion, behavioral organization, pain management, motor function, and sucking development.
Pacifier use reduces the risk of sudden infant death syndrome, and nonnutritive sucking has been shown to improve physiological balance and feeding in premature infants. Therefore, the risks and benefits of pacifier use should be carefully considered. In a study, it was reported that giving a pacifier on the 15th day did not change the prevalence and duration of breastfeeding, that using a pacifier was associated with a lower incidence of sudden infant death syndrome, and that giving a pacifier was a useful approach. Using a pacifier can help the baby calm down and adapt to the environment. When the literature was reviewed, conflicting results were reported regarding using a pacifier. However, the effect of using a pacifier on the baby's motor development and especially sensory processing skills has not been clearly investigated. The aim of this study was to evaluate babies using a pacifier in terms of both motor development and sensory processing skills and to compare them with their peers who did not use a pacifier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pacifier user | – | Behavioral: Test of sensory function in infants, Behavioral: The Peabody Developmental Motor Scales-Second Edition, Behavioral: Infant/toddler sensory profileFull-term infants who have used a pacifier for at least 6 months will be included in the study. The infants' motor development and sensory processing skills will be evaluated. |
| non-pacifier | – | Behavioral: Test of sensory function in infants, Behavioral: The Peabody Developmental Motor Scales-Second Edition, Behavioral: Infant/toddler sensory profileThe motor development and sensory processing skills of full-term infants who are 9-12 months old and do not use a pacifier will be evaluated. The developmental results of both groups will be compared |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full-term infants who have used a pacifier for at least 6 months and full-term infants who have never used a pacifier will be included in the study. The motor and sensory development of the included children will be compared according to their pacifier use status.
Key inclusion criteria (3 listed)
- Full-term infants who have used a pacifier for at least 6 months and are still using it,
- Babies who do not have sucking dysfunction and are breastfed for the first 6 months,
- Post-term infants who are between 9-12 months old
Key exclusion criteria (4 listed)
- Premature infants
- Infants with congenital malformations
- Infants diagnosed with metabolic, neurological and genetic diseases
- Children whose parents do not volunteer for the study
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 |
|---|---|---|
| Test of sensory function in infantsIt was planned to use the Test of sensory function in infants to evaluate the sensory development of infants. The test of sensory function in infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The test of sensory function in infants requires the infant to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has normative values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months. | Behavioural | non-pacifier, pacifier user |
| The Peabody Developmental Motor Scales-Second EditionThe Peabody Developmental Motor Scales-Second Edition is a standardized, norm-referenced assessment instrument designed to evaluate both gross and fine motor skills in children aged 0 to 71 months. It is frequently employed in clinical, educational, and research contexts to detect motor developmental delays, monitor developmental trajectories, and inform intervention strategies. Notably, higher scores on the scale reflect superior motor performance, indicating better developmental outcomes | Behavioural | non-pacifier, pacifier user |
| Infant/toddler sensory profileThe infant/toddler sensory profile is a questionnaire filled out by the child's primary caregiver to collect information about sensory processing abilities. The test evaluates sensory processing in 6 different areas. These items consist of general, visual, auditory, vestibular, tactile and oral sensory processing. The caregiver evaluates the child's behavior on a 5-point scale. One point means "almost always" and five points means "almost never". The caregiver's responses are summarized using standard scoring procedures and then interpreted in terms of the impact of a child's sensory processing abilities on the child and their family's lives. The scores are normative for age and are important in assessing sensory development. | Behavioural | non-pacifier, pacifier user |
Primary outcome
Peabody Developmental Motor Scales | Second Edition
Time frame: 9-12 months
The Peabody Developmental Motor Scales-Second Edition is a standardized, norm-referenced assessment instrument designed to evaluate both gross and fine motor skills in children aged 0 to 71 months. The Peabody Developmental Motor Scales-Second Edition comprises six subtests, namely Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, and Visual-Motor Integration, which collectively measure a broad spectrum of motor functions including postural control, locomotor abilities, object manipulation, and hand-eye coordination. The subtests generate three composite scores: the Gross Motor Quotient, Fine Motor Quotient, and Total Motor Quotient, offering a comprehensive evaluation of a child's motor competence. Notably, higher scores on the scale reflect superior motor performance, indicating better developmental outcomes
Test of Sensory Functions in Infants
Time frame: 9-12 months
It was planned to use the Test of sensory function in infants to evaluate the sensory development of infants. The test of sensory function in infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The test of sensory function in infants requires the infant to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has normative values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months.
Infant/toddler sensory profile
Time frame: 9-12 months
Infant/toddler sensory profile; The infant/toddler sensory profile is a questionnaire filled out by the child's primary caregiver to collect information about sensory processing abilities. It is a questionnaire that questions the behavior and performance of a child between the ages of 0-3 (0-7 months and 7-36 months) regarding sensory processing. The test evaluates sensory processing in 6 different areas. These items consist of general, visual, auditory, vestibular, tactile and oral sensory processing. The caregiver evaluates the child's behavior on a 5-point scale. One point means "almost always" and five points means "almost never". The caregiver's responses are summarized using standard scoring procedures and then interpreted in terms of the impact of a child's sensory processing abilities on the child and their family's lives. The scores are normative for age and are important in assessing sensory development.
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 26 Jun 2025.
- Results publication: PubMed 25462470Cabral TI, Pereira da Silva LG, Tudella E, Simoes Martinez CM. Motor development and sensory processing: A comparative study between preterm and term infants. Res Dev Disabil. 2015 Jan;36C:102-107. doi: 10.1016/j.ridd.2014.09.018. Epub 2014 Oct 16.
- Results publicationDunn, W. and D.B. Daniels, Initial development of the infant/toddler sensory profile. Journal of Early Intervention, 2002. 25(1): p. 27-41.
- Results publication: PubMed 12612229Howard CR, Howard FM, Lanphear B, Eberly S, deBlieck EA, Oakes D, Lawrence RA. Randomized clinical trial of pacifier use and bottle-feeding or cupfeeding and their effect on breastfeeding. Pediatrics. 2003 Mar;111(3):511-8. doi: 10.1542/peds.111.3.511.
- Results publication: PubMed 1353190Barnes DM, Hanby AM, Gillett CE, Mohammed S, Hodgson S, Bobrow LG, Leigh IM, Purkis T, MacGeoch C, Spurr NK, et al. Abnormal expression of wild type p53 protein in normal cells of a cancer family patient. Lancet. 1992 Aug 1;340(8814):259-63. doi: 10.1016/0140-6736(92)92354-i.
- 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.
Rabia ZORLULAR principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacifier and Infant Development, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 26 Jun 2025. 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 Turkey (Türkiye). 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 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?
Peabody Developmental Motor Scales | Second Edition (time frame: 9-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889441, which also lists 4 linked publications.
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 26 Jun 2025.