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Completed

NCT Number: NCT06889441

Pacifier Use and Infant 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.

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Key information

Conditions

Pacifier Infant Development Sensory Processing Disorder

Age range

9 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Premature infants
  • Infants with congenital malformations
  • Infants diagnosed with metabolic, neurological and genetic diseases
  • Children whose parents do not volunteer for the study

Treatment and study plan

Test of Sensory Function in Infants

Behavioral

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 Edition

Behavioral

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 profile

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Effect of Pacifier Use on Motor Development and Sensory Processing Skills in Infants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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