Pacifier Use and Infant Development

NCT06889441 | Completed

• 1 other identifier: pacifier use
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacifier; Infant Development; Sensory Processing Disorder

Keywords

Pacifier use; development; Sensory Processing Skills; motor development

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  9-12 months

Study Arms (2)

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.

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

Behavioral: Test of sensory function in infants; Behavioral: The Peabody Developmental Motor Scales-Second Edition; Behavioral: Infant/toddler sensory profile

Interventions

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.

non-pacifier; pacifier user

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

non-pacifier; pacifier user

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.

non-pacifier; pacifier user

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 25462470 BACKGROUND

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

  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.

  PMID: 12612229 BACKGROUND

• 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.

  PMID: 1353190 BACKGROUND

Study Officials

• Rabia ZORLULAR

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: March 21, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)