Clinical trial NCT06365164: Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex
Official title: Presence of the Rooting Reflex on Preterms' ? Study of the Emergence of Sensory Self-awareness in Premature Newborns: Comparison of the Rooting Reflex Response Between Facilitated Self-stimulation and External Stimulation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature
Development, Child
Rooting Reflex
Keywords: rooting reflex
sensory self-awareness
tactile sensory
premature newborn
development care
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Faculty of Psychology and Educational Sciences,University of Geneva
First posted: 2024-04-15
Enrollment: 19
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

Brief summary: The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.

The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.

The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

Detailed description: Touch is the first sense to develop in foetal life. Children born prematurely have early tactile skills, in particular the ability to discriminate and learn. These tactile skills can be expressed through the newborn's reflexes. The sensory exploration that takes place when reflexes are manifested can be the basis for tactile learning and, in particular, for the development of the baby's awareness of his own body, with discrimination of the self. As touch plays an essential role in the child's perceptual-cognitive development, studying the tactile skills of premature infants is an ideal approach for a better understanding of the development of primitive sensory awareness.

The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness, by comparing the response of the rooting reflex between facilitated self-stimulation and external stimulation.

The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

The study of the specific sensory of the premature newborn is part of the continuum of developmental care, and is part of an approach to improving the care delivered in neonatology with the aim of encouraging the best neurological development.

Eligibility criteria: Inclusion Criteria:

* Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

Exclusion Criteria: Premature newborns with :

* respiratory assistance (invasive or non-invasive ventilation)
* malformative syndrome
* a genetic syndrome
* neurological damage such as stage III or IV intraventricular haemorrhage or periventricular leukomalacia,
* sedative treatment: morphine, clonidine
* aminergic treatment
* acute pathology: shock, sepsis, acute cardiac failure, acute respiratory failure, etc.

Primary outcomes:
measure: The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.
timeFrame: The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.
Secondary outcomes:
measure: The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn.
timeFrame: Each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation. The data will be collected for one year. Each newborn baby can be included for 14 weeks.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
state: Isere
Study officials:
affiliation: University Grenoble Hospital
name: Julia Doutau
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lejeune F, Marcus L, Berne-Audeoud F, Streri A, Debillon T, Gentaz E. Intermanual transfer of shapes in preterm human infants from 33 to 34 + 6 weeks postconceptional age. Child Dev. 2012 May-Jun;83(3):794-800. doi: 10.1111/j.1467-8624.2012.01753.x. Epub 2012 Mar 30.
citation: Marcus L, Lejeune F, Berne-Audeoud F, Gentaz E, Debillon T. Tactile sensory capacity of the preterm infant: manual perception of shape from 28 gestational weeks. Pediatrics. 2012 Jul;130(1):e88-94. doi: 10.1542/peds.2011-3357. Epub 2012 Jun 25.
citation: Als H, McAnulty GB. The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) with Kangaroo Mother Care (KMC): Comprehensive Care for Preterm Infants. Curr Womens Health Rev. 2011 Aug;7(3):288-301. doi: 10.2174/157340411796355216.