NCT01274845

Brief Summary

The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

January 10, 2011

Last Update Submit

January 11, 2011

Conditions

Meconium Aspiration Syndrome

Keywords

Meconium aspiration syndromeHelioxMechanical ventilationNewborn

Outcome Measures

Primary Outcomes (1)

  • Changes in acid-base balance and oxygenation

    Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference.

    Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.

Secondary Outcomes (1)

  • Changes in respiratory parameters

    Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.

Study Arms (1)

Heliox

OTHER
Other: Heliox mechanical ventilation

Interventions

Heliox mechanical ventilationOTHER

Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.

Heliox

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • meconium aspiration syndrome diagnosed based on clinical and radiological findings,
  • respiratory failure requiring mechanical ventilation

You may not qualify if:

  • congenital malformations or congenital genetic syndromes,
  • persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology at Poznań University of Medical Sciences

Poznan, 60-535, Poland

Location

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Tomasz Szczapa, MD, PhD

    Department of Neonatology at Poznań University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 12, 2011

Record last verified: 2011-01

Locations

PL(1)