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

NCT03801785 | Unknown DMC

• 1 other identifier: OBG201803X004533
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Proprioceptive and exteroceptive development; Non-nutritive habit benefits; Thumb sucking; Pacifiers; Appropriate age to stop non-nutritive sucking; Dental problems; Theta Rhythm

Outcome Measures

Primary Outcomes (4)

• Children's postural balance force plates measured in millimeters.

  Multiple oscillation postural balance (swaying) measured by assessing the children's center of pressure on a stabilometric platform produced by Advanced Mechanical Technology Inc (AMTI). The X and Y axes oscillations will be aggregated by a Nexus software version 2.6 to arrive at one reported value for balance force plates in millimeters according to validated posture stability standards (Guffey et al., 2016).

  Changes in postural balance assessed from date of enrollment up to 36-months.

• Children's dynamic gait frequency assessed in steps/6-minute walking test.

  Gait analysis frequency assessing children's dynamic gait steps from video recorded films. The step frequency for dynamic gait will be measured by chronometer in steps during a 6-minute walking test.

  Changes in gait frequency assessed from date of enrollment up to 36-months.

• Children's step speed measured in meters/6-minute walking test.

  Children's step speed assessed from video-recorded films during walking. The step speed will be measured by chronometer in meters during a 6-minute walking test.

  Changes in step speed assessed from date of enrollment up to 36-months.

• Children's falls assessed as number of falls/6-minute walking test.

  Children's falls assessed from video-recorded films as number of falls during a 6-minute walking test. All the computerized photometric balance measures and gait analyses will be assessed at the Neuro-rehabilitation Unit in the OBG site at Palidoro with the PI supervision. Postural balance and gait measures will be assessed and compared with the average age-related standards.

  Changes in number of falls assessed from date of enrollment up to 36-months.

Secondary Outcomes (8)

• Overbite measured in millimeters during standard orthodontic assessment.

  Changes in overbite from date of enrollment up to 36 months.

• Overjet measured in millimeters during standard orthodontic assessment.

  Changes in overjet from date of enrollment up to 36 months.

• Brain areas elicitated by the NNS habit (theta-bands indicating pleasure and well-being including right and left cervico-parietal and temporo-occipital areas when children are falling asleep and sleep) recorded by EEGs at enrollment and 2 years later.

  At enrollment and 2 years later.

• Awake pacifier sucking or NNS time measured in hours.

  Changes in awake pacifier sucking or NNS measured from date of enrollment up to 36 months.

• Crying time measured in minutes of crying/day.

  Changes in crying time measured from date of enrollment up to 36 months.

Other Outcomes (3)

• Child's age in months when parents first tried to stop NNS.

  At enrollment.

• Parents' reasons for inducing children to stop NNS habits reported in a list including percentages.

  At enrollment.

• How parents tried to stop NNS habits reported in a list including percentages.

  At enrollment.

Study Arms (2)

Children induced to suck pacifiers.

EXPERIMENTAL

Children will suck a pacifier of identical shape and type and will be allowed other NNS habits.

Other: Pacifier

Children induced to stop sucking.

NO INTERVENTION

Children will be induced by DDSs to stop sucking and their parents will be advised how to stop their children's NNS habits.

Interventions

Pacifier OTHER

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.

Children induced to suck pacifiers.

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy boys and girls ranging in age from 12 to 42 months who tended to prolong NNS.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• Artsana S.p.a.: collaborator

Study Sites (1)

Bambino Gesù Children's Hospital and Research Institute

Roma, 00165, Italy

RECRUITING

Related Publications (4)

• Guffey K, Regier M, Mancinelli C, Pergami P. Gait parameters associated with balance in healthy 2- to 4-year-old children. Gait Posture. 2016 Jan;43:165-9. doi: 10.1016/j.gaitpost.2015.09.017. Epub 2015 Sep 30.

  PMID: 26439183 BACKGROUND

• Lehtonen J, Valkonen-Korhonen M, Georgiadis S, Tarvainen MP, Lappi H, Niskanen JP, Paakkonen A, Karjalainen PA. Nutritive sucking induces age-specific EEG-changes in 0-24 week-old infants. Infant Behav Dev. 2016 Nov;45(Pt A):98-108. doi: 10.1016/j.infbeh.2016.10.005. Epub 2016 Oct 26.

  PMID: 27792918 BACKGROUND

• Maulsby RL. An illustration of emotionally evoked theta rhythm in infancy: hedonic hypersynchrony. Electroencephalogr Clin Neurophysiol. 1971 Aug;31(2):157-65. doi: 10.1016/0013-4694(71)90186-6. No abstract available.

  PMID: 4104705 BACKGROUND

• Vadiakas G, Oulis C, Berdouses E. Profile of non-nutritive sucking habits in relation to nursing behavior in pre-school children. J Clin Pediatr Dent. 1998 Winter;22(2):133-6.

  PMID: 9643187 BACKGROUND

Related Links

• Excessive pressure to stop the NNS habits in children before 4 years of age can do more harm than good.
• British Orthodontic Society recommendations: dummy habits tend to stop before the adult teeth appear at age 6. Beyond 7-year age, problems with the teeth position may occur.
• Paola Rosati - Poster on the proprioceptive benefits from NNS habits in children presented at the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference, April 2-4, 2017, Leiden, Netherlands (abstract book N. 2.34 page 111)

MeSH Terms

Conditions

Fingersucking

Interventions

Pacifiers

Condition Hierarchy (Ancestors)

Habits; Behavior

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies

Study Officials

• Paola ROSATI, MD MSc

  Bambino Gesù Children's Hospital IRCCS Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola ROSATI, MD MSc

CONTACT

+39 06 6859; paola.rosati@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Model Details: The RCT includes two parallel arms. In the intervention arm, children will suck a pacifier of identical shape and type. In the control arm, children will be induced by the DDSs to stop sucking. Children's parents will be also advised by an ad hoc information sheet how to stop their children's NNS habit. Children in both arms will undergo computerized postural balancing and gait control measures every 6 months up to 36 months by video-recordings done at home or at the OBG site in Palidoro (Rome). Children in the two arms will also undergo an EEG while sucking, at enrolment and when follow-up ends. Parents will report in a diary time spent by their children on pacifier or finger-thumb sucking, crying time, afternoon and night-time sleep induction, awakenings, and day-sleep hours. Every 6 months, parents will bring the children and the diaries to the hospital. DDSs will visit the child, record oral examinations, and also report findings from parents' diaries in electronic and paper CRF.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 14, 2019
• Study Start: November 10, 2019
• Primary Completion: December 1, 2024
• Study Completion: March 30, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)