NCT01664832

Brief Summary

The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS). Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

Trial Health

55
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Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

August 2, 2012

Last Update Submit

June 26, 2013

Conditions

Respiratory Distress Syndrome

Keywords

Premature Infantssnychronized ventilationnon-invasive ventilationRDS

Outcome Measures

Primary Outcomes (1)

  • phasic esophageal pressure deflection

    4 hours

Secondary Outcomes (2)

  • Cerebral oxygen saturation

    4 hours

  • Arterial oxygen saturation

    4 hours

Study Arms (2)

S-nIMV

EXPERIMENTAL

nIMV synchronized using abdominal pressure capsule sensor device

Device: S-nIMV

nIMV

PLACEBO COMPARATOR

non-synchronized nasal intermittent mandatory ventilation group

Device: S-nIMV

Interventions

S-nIMVDEVICE

Synchronization of nasal breaths to infant's own respiratory effort

S-nIMVnIMV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
  • Gestational age \<32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
  • Informed consent available.

You may not qualify if:

  • Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital University of Ulm

Ulm, Baden-Wüttemberg, 89075, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Hummler Helmut, Prof. Dr

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helmut Hummle, Prof. Dr.

CONTACT

0731-500-57168helmut.hummler@uniklinik-ulm.de

Li Huang, Master

CONTACT

015776891592hhuangli@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Helmut Hummler

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 14, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

DE(1)