Clinical trial NCT05898295: Assessment of the Behavior of the Preterm Newborns
Official title: Assessment of the Behavior of the Preterm Newborn: Discriminative and Predictive Capacity of the Sensory-motor Behavior Observation Grid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: premature birth
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children born before 37+0/7 weeks of gestation and hospitalized in the NICU of Geneva hospitals are recruited. At least one French speaking parent is required to ensure parents understand the study.

Children are recruited before 1 month of corrected age appointment.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion cirteria

Primary outcomes:
measure: Assessing the ability of the OSMB grid to discriminate the sensory-motor status of the preterm newborn in routine neonatal care practice
timeFrame: between birth and hospital discharge (up to 200days)
measure: 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
timeFrame: between 37 and 40weeks of gestational age
measure: 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
timeFrame: and 1 month of corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hopitaux Universitaire de Genève
Study officials:
References: