Sleep Clinical Trial
— NNSbenefitsOfficial title:
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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 30, 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 42 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Bambino Gesù Children's Hospital and Research Institute | Roma |
Lead Sponsor | Collaborator |
---|---|
Bambino Gesù Hospital and Research Institute | Artsana S.p.a. |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Child's age in months when parents first tried to stop NNS. | Child's age in months when parents first tried to stop NNS, collected from parents by DDSs during the clinical history. | At enrollment. | |
Other | Parents' reasons for inducing children to stop NNS habits reported in a list including percentages. | Qualitative information collected from parents by DDSs during the clinical history. | At enrollment. | |
Other | How parents tried to stop NNS habits reported in a list including percentages. | Qualitative information collected from parents by DDSs during the clinical history. | At enrollment. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Overbite measured in millimeters during standard orthodontic assessment. | DDSs will evaluate the overbite millimetric measurement calibrated for each patient and documented by intraoral photographs obtained at enrollment and every 6 months in all the children enrolled. | Changes in overbite from date of enrollment up to 36 months. | |
Secondary | Overjet measured in millimeters during standard orthodontic assessment. | DDSs will evaluate the overjet millimetric measurement calibrated for each patient and documented by intraoral photographs obtained at enrollment and every 6 months in all the children enrolled. | Changes in overjet from date of enrollment up to 36 months. | |
Secondary | 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. | The EEG recorded during sucking with a pacifier or with a finger, done at enrollment and 2 years later, will identify the brain areas stimulated by NNS. These brain areas will be compared and correlated with muscle relaxation and sleep induction in the two population arms. | At enrollment and 2 years later. | |
Secondary | Awake pacifier sucking or NNS time measured in hours. | Time in hours spent on awake pacifier sucking or NNS habits assessed from parents' questionnaires collected by the DDS every 6 months. | Changes in awake pacifier sucking or NNS measured from date of enrollment up to 36 months. | |
Secondary | Crying time measured in minutes of crying/day. | Time in minutes spent on crying during the day assessed from parents' questionnaires collected by the DDS every 6 months. | Changes in crying time measured from date of enrollment up to 36 months. | |
Secondary | Sleep induction time measured in minutes/afternoon or /night-time sleep. | Minutes spent on sleep induction assessed from parents' questionnaires collected by the DDS every 6 months. | Changes in sleep induction measured from date of enrollment up to 36 months. | |
Secondary | Awakenings measured in number of awakenings/afternoon or /night-time sleep. | Number of awakenings during afternoon or night-time sleep assessed from parents' questionnaires collected by the DDS every 6 months. | Changes in number of awakenings measured from date of enrollment up to 36 months. | |
Secondary | Afternoon and night-time sleep duration measured in hours/day. | Duration in hours of continuous afternoon or night-time sleep assessed from parents' questionnaires collected by the DDS every 6 months. | Changes in duration of afternoon or night-time sleep assessed from enrollment up to 36 months. |
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