Assessment of the Behavior of the Preterm Newborns

NCT05898295 | Unknown

• 1 other identifier: ID 2020-00572
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

premature birth

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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

Interventions

no intervention OTHER

No intervention: only observation of the child behavior

Eligibility Criteria

• Age: 3 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hopitaux Universitaire de Genève

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 12, 2023
• Study Start: February 19, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)