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Terminated Not applicable Interventional

Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants

ClinicalTrials.gov ID: NCT01773746

Public ClinicalTrials.gov record NCT01773746. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 4:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

Study identification

NCT ID
NCT01773746
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sharp HealthCare
Other
Enrollment
80 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2013
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update posted
Sep 11, 2018

2013 – 2017

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Sharp Mary Birch Hospital for Women and Newborns San Diego California 92123
Connecticut Children's Medical Center Farmington Connecticut 06030-2948
University of Miami Miller School of Medicine Miami Florida 33101
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756
Oklahoma University Health Sciences Center Oklahoma City Oklahoma 73104
OU - Tulsa - Saint Francis Hospital Tulsa Oklahoma 74135

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01773746, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 11, 2018 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01773746 live on ClinicalTrials.gov.

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