NCT02743988

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%.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

April 7, 2016

Last Update Submit

April 14, 2016

Conditions

Intermittent HypoxemiaApnea of Prematurity

Keywords

cerebral oxygenationNIRSnear-infrared spectroscopybradycardiahypoxemiacerebral perfusioncardiac outputapneadesaturationoxygen saturation target range

Outcome Measures

Primary Outcomes (1)

  • Duration SpO2 < 80%

    during 16 hours of measurement

Secondary Outcomes (7)

  • Cerebral tissue oxygen saturation as measured by NIRS

    during 16 hours of measurement

  • Arterial SpO2 as measured by pulse oxymetry

    during 16 hours of measurement

  • Heart rate as measured by ECG

    during 16 hours of measurement

  • cerebral and visceral fractional oxygen extraction as measured by NIRS

    during 16 hours of measurement

  • Cardiac output as measured by Cardiovelocimetry

    during 16 hours of measurement

  • +2 more secondary outcomes

Study Arms (2)

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

OxygenDRUG

Adapt inspired oxygen to achieve desired SpO2 target range

High target rangeLow target range

Eligibility Criteria

Age21 Days - 42 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center, Ulm University

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

MeSH Terms

Conditions

ApneaBradycardiaHypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Central Study Contacts

Manuel B Schmid, MD

CONTACT

+41762515201manuel.schmid@uni-ulm.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 19, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

September 1, 2017

Last Updated

April 19, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)