No intervention in Premature Birth - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Premature Birth

Intervention / Treatment

Other: no intervention

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Geneva, Switzerland, 1211
    - Recruiting
    - Hopitaux Universitaire de Geneve
    - Contact:
      
      Cristina Borradori Tolsa, PD
      
      Phone Number: +41 0795532607
      
      Email: Cristina.BorradoriTolsa@hcuge.ch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

No exclusion cirteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the ability of the OSMB grid to discriminate the sensory-motor status of the preterm newborn in routine neonatal care practice Time Frame: 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	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 Time Frame: between 37 and 40weeks of gestational 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 Time Frame: and 1 month of corrected age	Evaluation of newborns' development using the Observation of Sensory-Motor Behavior (OSMB) grid	and 1 month of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)