Health TrialsbyHealthPanel

DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)

ConditionNeonatal Respiratory Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age72-10
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neonates born at ≤ 32 weeks GA (gestational age)

Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)

Receiving CPAP since > 24 hours at inclusion

Equipped with EAdi catheters.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP

    Device

    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP

    Device

    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP

    Device

    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP

    Device

    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)Experimental treatment 1 intervention
Group B: BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)Experimental treatment 1 intervention
Group C: ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)Experimental treatment 1 intervention
Group D: BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean swing EAdi (µV)

EAdi will be recorded during each ventilation period with CF-CPAP or VF-CPAP and the mean swing EAdi will be calculated after a 30 minutes wash-out period for each ventilation period

Time frame
Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period

Secondary outcomes

1

COMFORTneo score

A higher score indicates higher pain/discomfort Scores of COMFORTneo scale : * excessive: score \<11 * appropriate: score between 11 to 13 * insufficient : score \>13

Time frame
At the beginning and at the end of each ventilation period, up to 2 hours
2

Transcutaneous CO2 pressure TcPCO2 (mm Hg)

Time frame
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period
3

Heart rate beats per minute (bpm)

Time frame
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
4

Respiratory rate cycles/minute

Time frame
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Pr Xavier DURRMEYER

Collaborator

Source ClinicalTrials.gov
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