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Heliox in Preterm Infants With Respiratory Distress Syndrome

Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01759316
Enrollment
36
Registered
2013-01-03
Start date
2012-12-31
Completion date
2013-08-31
Last updated
2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Brief summary

Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Detailed description

Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation. Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

Interventions

OTHERheliox

heliox or oxygen is used in the two groups respectively

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
No

Inclusion criteria

* Gestational age more than 28 weeks and less than 32 weeks * Diagnosed as respiratory distress syndrome * Need to use NIPPV ventilation * No congenital diseases or hereditary diseases * With an informed consent form

Exclusion criteria

* With congenital diseases or hereditary diseases * Intubated in the delivery room * Need surgery

Design outcomes

Primary

MeasureTime frameDescription
length of ventilation and risk of mechanical ventilationparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksThe primary outcome is the length of ventilation and risk of mechanical ventilation of participants.

Secondary

MeasureTime frame
Transcutaneous blood gas analysis,ventilator parameters and lung inflammation cytokinesparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026