Assessment of the Behavior of the Preterm Newborns

Premature Birth Clinical Trial

— GOCSM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898295
• Other study ID #: ID 2020-00572
• Status: Recruiting
• Start date: February 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 6 Months

Eligibility

Inclusion Criteria:

• <37weeks

• Hospitalized in Geneva Hospital NICU

• At least one parent speaking french

Exclusion Criteria:

• No exclusion cirteria

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• no intervention
No intervention: only observation of the child behavior

Locations

Country	Name	City	State
Switzerland	Hopitaux Universitaire de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the ability of the OSMB grid to discriminate the sensory-motor status of the preterm newborn in routine neonatal care practice	Observation of the child's behavior during a disstimulating treatment and during a stabilizing treatment using the Observation of Sensory-Motor Behavior (OSMB) grid	between birth and hospital discharge (up to 200days)
Primary	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	Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid	between 37 and 40weeks of gestational age
Primary	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	Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid	and 1 month of corrected age