Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex

NCT ID: NCT06365164

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Premature Development, Child Rooting Reflex

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature newborns

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

Tactile stimulation

Intervention Type BEHAVIORAL

The procedure consists of brief perioral tactile stimulation. The procedure is filmed in order to record and evaluate the response of the newborn to the stimulation. During the same intervention, each newborn will receive external stimulation (the experimenter repeatedly and regularly touches the corner of the infant's mouth slowly with the tip of his index finger) followed by facilitated self-stimulation (the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand). There will also be an initial phase and a final 30-second phase in which the newborn is observed without any stimulation.

Interventions

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Tactile stimulation

The procedure consists of brief perioral tactile stimulation. The procedure is filmed in order to record and evaluate the response of the newborn to the stimulation. During the same intervention, each newborn will receive external stimulation (the experimenter repeatedly and regularly touches the corner of the infant's mouth slowly with the tip of his index finger) followed by facilitated self-stimulation (the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand). There will also be an initial phase and a final 30-second phase in which the newborn is observed without any stimulation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Psychology and Educational Sciences,University of Geneva

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Doutau

Role: PRINCIPAL_INVESTIGATOR

University Grenoble Hospital

Locations

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University Hospital Grenoble

Grenoble, Isere, France

Site Status

Countries

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France

Central Contacts

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Julia Doutau, Doctor

Role: CONTACT

0476765577

Alessia Touraton

Role: CONTACT

0476765577

References

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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.

Reference Type BACKGROUND
PMID: 22469180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22732168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25473384 (View on PubMed)

Related Links

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Other Identifiers

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38RC23.0354

Identifier Type: -

Identifier Source: org_study_id

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