GOCSM: Assessment of the Behavior of the Preterm Newborns

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898295

Collaborator

(none)

100

Enrollment

Location

46.4

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Other: no intervention

Detailed Description

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Assessment of the Behavior of the Preterm Newborn: Discriminative and Predictive Capacity of the Sensory-motor Behavior Observation Grid

Actual Study Start Date :

Feb 19, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Assessing the ability of the OSMB grid to discriminate the sensory-motor status of the preterm newborn in routine neonatal care practice [between birth and hospital discharge (up to 200days)]
Observation of the child's behavior during a disstimulating treatment and during a stabilizing treatment using the Observation of Sensory-Motor Behavior (OSMB) grid
To evaluate the predictive capacity of the child's later psychomotor development on the basis of the items from the sensorimotor assessment thanks to the OCSM grid, at term equivalent age [between 37 and 40weeks of gestational age]
Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid
To evaluate the predictive capacity of the child's later psychomotor development on the basis of the items from the sensorimotor assessment thanks to the OCSM grid, at term equivalent age [and 1 month of corrected age]
Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Days to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

No exclusion cirteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopitaux Universitaire de Genève	Geneva		Switzerland	1211

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cristina Borradori Tolsa, principal investigator, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT05898295

Other Study ID Numbers:

ID 2020-00572

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cristina Borradori Tolsa, principal investigator, University Hospital, Geneva

premature birth

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jun 12, 2023