Assessment of the Behavior of the Preterm Newborns

NCT ID: NCT05898295

Last Updated: 2023-06-12

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2024-12-31

Brief Summary

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The project presented here aims to evaluate the discrimination capacity of the Observation of Sensory-Motor Behavior (OSMB) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development.

To do this, OSMB grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. In addition, an OSMB grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. The OCSM scores will then be compared to the Bayley III scale scores at 6 months of age corrected for prematurity.

Detailed Description

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The project presented here aims to evaluate the discrimination capacity of the Observation of Sensory-Motor Behavior (OSMB) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development.

To do this, OSMB grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. In addition, an OSMB grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. The OCSM scores will then be compared to the Bayley III scale scores at 6 months of age corrected for prematurity.

Conditions

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Premature Birth

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

No intervention: only observation of the child behavior

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \<37weeks
* Hospitalized in Geneva Hospital NICU
* At least one parent speaking french

Exclusion Criteria

* No exclusion cirteria
Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Cristina Borradori Tolsa

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopitaux Universitaire de Genève

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Cristina Borradori Tolsa, PD

Role: primary

0795532607 ext. +41

Other Identifiers

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ID 2020-00572

Identifier Type: -

Identifier Source: org_study_id

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