Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

NCT ID: NCT02743988

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intermittent Hypoxemia Apnea of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low target range

Low oxygen saturation target range: SpO2 85-89%

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Adapt inspired oxygen to achieve desired SpO2 target range

High target range

High oxygen saturation target range: SpO2 91-95%

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Adapt inspired oxygen to achieve desired SpO2 target range

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxygen

Adapt inspired oxygen to achieve desired SpO2 target range

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Days

Maximum Eligible Age

42 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Manuel Schmid

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center, Ulm University

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Manuel B Schmid, MD

Role: CONTACT

+41762515201

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Manuel B Schmid

Role: primary

+49 731 500 ext. 57218

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ULMNEONIRS05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.