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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03438071
Other study ID # VISIO-NEONAT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 21, 2018
Est. completion date September 7, 2018

Study information

Verified date May 2020
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 7, 2018
Est. primary completion date August 18, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our NICU during recrutment period

- Which agreed participating to the study after having complete information about it and sign a consent.

Exclusion Criteria:

- Parents with a preterm child with another pathology than prematurity or with a lenght of stay in the NICU less than 7 days

- Parents refusing to participate to the study

- Parents not having videoconference equipment or internet access at home

- Parents not understanding or speaking good enough French.

Study Design


Intervention

Other:
Videoconferencing
Daily videoconference updates using Skype between parents of preterm infants hospitalized in NICU and the nurse taking care of their child, lasting 5 to 10 minutes, to check with her for the daily news and then see their child through the camera.

Locations

Country Name City State
France CHU DE Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of stress of the mothers Mean score of the mothers of preterm infants hospitalized in NICU on the PSS-NICU (Parental Stressor Scale NICU), measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups. From date of inclusion until the date of discharge, assessed up to 1 month
Secondary Level of stress of the fathers Mean score of the fathers of preterm infants hospitalized in NICU on the PSS-NICU, measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups. From date of inclusion until the date of discharge, assessed up to 1 month
Secondary Parental stress evolution Evolution of the PSS-NICU score of both parents between the inclusion in the study and the last evaluation before their child's discharge of the NICU, in the 2 groups. From the date of inclusion until the date of discharge, assessed up to 1 month
Secondary Post-partum depression rate of the mothers Score of the mothers of preterm infants hospitalized in NICU on the EPDS (Edinburgh Post-natal Depression Scale), measured at the inclusion, at discharge and a month later, in the 2 groups. Through study completion, an average of 2 months
Secondary Quality of the relationship between the parents and their child Mean score of both parents of preterm infants hospitalized in NICU on the PBQ (Post-partum Bonding Questionnaire), measured once a week during all the last of their child's hospitalization in the unit and a month after his discharge, in the 2 groups. Through study completion, an average of 2 months
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