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Completed

NCT Number: NCT02620891

Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

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.

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Key information

Conditions

Neonatal Meconium Aspiration Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Infant, Newborn, Diseases Lung Diseases Lung Injury Meconium Aspiration Syndrome Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

37 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has the diagnosis of neonatal meconium aspiration syndrome
  • Subject has Synchronous instruction ventilation

Exclusion criteria

  • History of congenital or hereditary disease

Treatment and study plan

helium oxygen mixture

Device

Other names: Air oxygen mixture

Primary outcomes

  1. blood gas analysis

    Time frame: 2 hour

    Time detection after treatment

  2. blood gas analysis

    Time frame: 6 hour

  3. blood gas analysis

    Time frame: 12 hour

  4. blood gas analysis

    Time frame: 24 hour

  5. blood gas analysis

    Time frame: 48 hour

Secondary outcomes

  1. Inflammatory response index (IL-6,IL-8, TNF-a,CRP)

    Time frame: 0 hour

  2. Inflammatory response index (IL-6,IL-8, TNF-a,CRP)

    Time frame: 6 hour

Other outcomes

  1. Amplitude integrated electroencephalogram

    Time frame: 28and 100 days

  2. Amplitude integrated electroencephalogram

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

Ma Juan

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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