Efficacy of Non-Nutritive Sucking (NNS) on Balance and Gait Measured in 12-42 Month-Old Healthy Children Over 36 Months

Summary

No one disputes that fetal sucking in the womb is a natural human right. Available information on whether, how and when to stop children's sucking habits comes from popular cultural misunderstandings and lack of sound evidence-based results. Because Western countries regard thumb or pacifier (dummy) sucking after a given age as a shameful habit, parents feel stressed, anxious and even guilty for being unable to induce their children to stop non-nutritive sucking (NNS) habits or drag their unwilling child off the soothing-devices, such as pacifiers. Pacifier sucking substantially decreases the incidence of sudden infant death syndrome, reduces pain and crying, and prolongs sleeping time. Of major interest is the hypothesis that NNS improves proprioceptive and exteroceptive development including gait in big mammals (rhesus monkeys). Despite these benefits, available information claims the possible risks induced by prolonging NNS, including psychological shortfall, delayed language skills or dental problems. Despite these claims, authoritative clinical organizations worldwide reach no consensus on the appropriate age at which NNS habits should be stopped. Prompted by conflicting information from primary studies and reviews designed to balance the benefits and risks of NNS habits, our aim in this pilot open randomized controlled trial (RCT) is to test the efficacy of NNS in improving balance and gait in children enrolled at 12-42 months and followed for three years.

Conditions

• Postural Balance
• Gait
• Non-nutritive Sucking
• Sleep
• Muscle Relaxation
• Electroencephalography

Interventions

OTHER

Pacifier

The pacifiers used in this clinical trial have the same shape and material. They are produced by Artsana S.P.A. for soothing children. As such, the FDA has no jurisdictions over pacifiers (US FDA regulations May 15, 2012 https://www.fdaimports.com/blog/pacifiers-fda-change-abi-system/) because they are not medical devices intended for teething.

Sponsors & Collaborators

• Artsana S.p.a.

  collaborator INDUSTRY

• Bambino Gesù Hospital and Research Institute

  lead OTHER

Principal Investigators

• Paola ROSATI, MD MSc · Bambino Gesù Children's Hospital IRCCS Rome

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

42 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-10

Primary Completion

2024-12-31

Completion

2025-03-30

Countries

• Italy

Study Locations