Clinical trial NCT06889441: Pacifier Use and Infant Development
Official title: Effect of Pacifier Use on Motor Development and Sensory Processing Skills in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pacifier
Infant Development
Sensory Processing Disorder
Keywords: Pacifier use
development
Sensory Processing Skills
motor development
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Peabody Developmental Motor Scales | Second Edition
timeFrame: 9-12 months
measure: Test of Sensory Functions in Infants
timeFrame: 9-12 months
measure: Infant/toddler sensory profile
timeFrame: 9-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Rabia ZORLULAR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dunn, W. and D.B. Daniels, Initial development of the infant/toddler sensory profile. Journal of Early Intervention, 2002. 25(1): p. 27-41.
citation: 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.
citation: 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.