Influence of Oxygen Target Range on Intermittent Hypoxemi... | NCT02743988

Studies
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

NCT02743988

Sponsor

University of Ulm

Status

Unknown status

Last Update Posted

Apr 19, 2016Estimated

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Intermittent Hypoxemia
Apnea of Prematurity

Interventions

Oxygen

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Apr 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Apr 7, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation < 80%.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low target range	Experimental	Low oxygen saturation target range: SpO2 85-89%	Drug: Oxygen
High target range	Active Comparator	High oxygen saturation target range: SpO2 91-95%	Drug: Oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen	Drug	Adapt inspired oxygen to achieve desired SpO2 target range	High target range Low target range

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration SpO2 < 80%		during 16 hours of measurement

Secondary Outcomes

Measure	Description	Time Frame
Cerebral tissue oxygen saturation as measured by NIRS	Area under threshold	during 16 hours of measurement
Arterial SpO2 as measured by pulse oxymetry	Area under 80%

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preterm infant < 29 weeks gestation
at least 8 hypoxemic events during 8 hours
requires supplemental oxygen to achieve high SpO2 target range
parental consent given

Exclusion Criteria:

congenital life-threatening malformation
fatal outcome expected
airway malformation
higher grade intraventricular bleeding (grade III or IV according to LA Papile)
posthaemorrhagic hydrocephalus
life-threatening disease at the time of study entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Days

Maximum Age

42 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manuel B Schmid, MD	Contact	+41762515201		manuel.schmid@uni-ulm.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center, Ulm University	Recruiting	Ulm	Baden-Wurttemberg	89075	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea
D001919	Bradycardia
D000860	Hypoxia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010100	Oxygen

Ancestor Terms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases

Browse Leaves

Not provided

Browse Branches

Not provided