NCT03438071

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2018

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

February 4, 2018

Last Update Submit

May 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Level of stress of the fathers

    From date of inclusion until the date of discharge, assessed up to 1 month

  • Parental stress evolution

    From the date of inclusion until the date of discharge, assessed up to 1 month

  • Post-partum depression rate of the mothers

    Through study completion, an average of 2 months

  • Quality of the relationship between the parents and their child

    Through study completion, an average of 2 months

Study Arms (2)

Control group

Videoconference group

Other: Videoconferencing

Interventions

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.

Videoconference group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 preterm infants and their parents (15 in each group)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU DE Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Denis Oriot

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 19, 2018

Study Start

February 21, 2018

Primary Completion

August 18, 2018

Study Completion

September 7, 2018

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations