Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Neonatal Meconium Aspiration Clinical Trial

Official title:

Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620891
• Other study ID #: MJuan
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: January 2020
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helium—oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

• Subject has the diagnosis of neonatal meconium aspiration syndrome

• Subject has Synchronous instruction ventilation

Exclusion Criteria:

• History of congenital or hereditary disease

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Neonatal Meconium Aspiration

Intervention

Device:
• helium oxygen mixture

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Ma Juan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amplitude integrated electroencephalogram		28and 100 days
Other	Amplitude integrated electroencephalogram		100 days
Primary	blood gas analysis	Time detection after treatment	2 hour
Primary	blood gas analysis		6 hour
Primary	blood gas analysis		12 hour
Primary	blood gas analysis		24 hour
Primary	blood gas analysis		48 hour
Secondary	Inflammatory response index (IL-6,IL-8, TNF-a,CRP)		0 hour
Secondary	Inflammatory response index (IL-6,IL-8, TNF-a,CRP)		6 hour