NCT03827252

Brief Summary

The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2020

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

January 31, 2019

Last Update Submit

May 9, 2023

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (1)

  • Cardio-respiratory coordination index

    Percentage of time during the recording that fulfills the criteria of coordination ( \> 0.7 amplitude of spectra in coordigram)

    10 days

Secondary Outcomes (3)

  • Cardio-respiratory coordination index by phase analysis technique

    10 days

  • Correlation between cardio-respiratory coordination index and SaO2

    10 days

  • Correlation of temperatures (infant, parent) and cardio-respiratory coordination index

    10 days

Eligibility Criteria

Age28 Weeks - 36 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age

You may qualify if:

  • Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
  • At least 72 hours postnatal age
  • Benefiting skin-to-skin care

You may not qualify if:

  • Severe congenital malformation and nervous system dysfunction (e.g., Ondine Sd)
  • Septic shock
  • Mechanical ventilation support
  • Severe pulmonary arterial hypertension
  • Analgesia morphinics at high dosage and curare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80000, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 1, 2019

Study Start

September 7, 2018

Primary Completion

December 11, 2019

Study Completion

September 12, 2020

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)