Assessment of the Behavior of the Preterm Newborns

Recruiting

• Conditions: Premature Birth

• Registration Number: NCT05898295
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-19
• Study First Submitted: 2023-05-10
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• No exclusion cirteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	and 1 month of corrected age	Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid

Trial Locations

Locations (1)

Hopitaux Universitaire de Genève; 🇨🇭 Geneva, Switzerland