Pacifier Use and Infant Development

NCT ID: NCT06889441

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2025-06-01

Brief 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. 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.

Conditions

Pacifier; Infant Development; Sensory Processing Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Test of sensory function in infants

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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

Test of sensory function in infants

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

Test of sensory function 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.

Intervention Type: BEHAVIORAL

The 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. 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

Intervention Type: BEHAVIORAL

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. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Rabia ZORLULAR

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia ZORLULAR

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Locations

Nigde Omer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 25462470 (View on PubMed)

Dunn, W. and D.B. Daniels, Initial development of the infant/toddler sensory profile. Journal of Early Intervention, 2002. 25(1): p. 27-41.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12612229 (View on PubMed)

Barnes 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.

Reference Type: BACKGROUND

PMID: 1353190 (View on PubMed)

Other Identifiers

pacifier use

Identifier Type: -

Identifier Source: org_study_id