NCT02893956

Brief Summary

Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it. Study design Prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age \< 48 hours, and requiring invasive mechanical ventilation. Crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support. The objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow. The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

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

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

July 21, 2016

Last Update Submit

September 2, 2016

Conditions

Premature Newborn

Keywords

Echocardiographypostural supportpreterm neonate

Outcome Measures

Primary Outcomes (2)

  • value of the ratio of the acceleration time of pulmonary arterial flow.

    for each echocardiography (support condition and postural support)

    up to 1 hour

  • value of the ejection time of pulmonary arterial flow

    for each echocardiography (support condition and postural support)

    up to 1 hour

Secondary Outcomes (3)

  • pain assessment with a clinical scale

    up to 1 hour

  • number of participant with a Patent ductus arteriosus shunt

    up to 2 hours

  • systolic pulmonary arterial pressure

    up to 2 hour

Study Arms (2)

echocardiography with postural support then standard condition

EXPERIMENTAL

the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition

Procedure: echocardiography with postural supportProcedure: echocardiography with standard condition (usual)

echocardiography with standard condition then support postural

ACTIVE COMPARATOR

the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support

Procedure: echocardiography with postural supportProcedure: echocardiography with standard condition (usual)

Interventions

echocardiography with postural supportPROCEDURE
echocardiography with postural support then standard conditionechocardiography with standard condition then support postural
echocardiography with standard condition (usual)PROCEDURE
echocardiography with postural support then standard conditionechocardiography with standard condition then support postural

Eligibility Criteria

Age1 Minute - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn than 30 weeks of gestation neonates,
  • Newborn with a post natal age \< 48 hours,
  • Newborn requiring invasive mechanical ventilation.
  • Signed consent form of parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

September 9, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)