Effects of pacifier sucking on balance and gait in young children
Examining the Efficacy of Pacifiers (Dummies) and Non-Nutritive Sucking (NNS) Habits in Improving Balance and Gait in 12-42 Month-Old Healthy Children Followed for 36 Months
This study is testing if using pacifiers can help young children aged 12 to 42 months improve their balance and walking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 12 Months to 42 Months |
| Sex | All |
| Sponsor | Bambino Gesù Hospital and Research Institute Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT03801785 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the efficacy of non-nutritive sucking (NNS) using pacifiers on improving balance and gait in healthy children aged 12 to 42 months. Over a three-year period, children will be enrolled and divided into two groups: one group will use pacifiers while the other will not. The study will measure outcomes related to postural balance and gait after a two-year follow-up. The trial will adhere to good clinical practice guidelines and will involve detailed data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 12 to 42 months who have a tendency to prolong non-nutritive sucking habits.
Not a fit: Children with craniofacial malformations, known genetic syndromes, or atypical swallowing issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence-based guidance on the benefits of non-nutritive sucking for children's motor development.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated potential benefits of non-nutritive sucking in infants, suggesting a promising area for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria • Healthy boys and girls ranging in age from 12 to 42 months who tended to prolong NNS. Exclusion criteria * Children with craniofacial malformations or with a known or clinically suspected genetic syndrome (for example Down syndrome); * Children with atypical swallowing for example tongue interposition, or dysphagia during swallowing caused by tongue interposition; * Children who already have mixed dentition.
Where this trial is running
Roma
- Bambino Gesù Children's Hospital and Research Institute — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Paola ROSATI, MD MSc — Bambino Gesù Children's Hospital IRCCS Rome
- Study coordinator: Paola ROSATI, MD MSc
- Email: paola.rosati@opbg.net
- Phone: +39 06 6859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.