Clinical trial NCT01773746: Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants
Official title: The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Extreme Prematurity - Less Than 28 Weeks
Keywords: neonatal
resuscitation
room air
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2013-01-23
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The Premature Infants Resuscitated with Oxygen or Air (PRESOX) trial, is a prospective randomized clinical trial of extremely premature infants that will assess the use of a low and high oxygen concentration for the initial resuscitation. The hypothesis is that infants resuscitated with a lower oxygen concentration at birth will have a increase in survival without bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP) during their initial hospitalization, and will have a increase in survival without neurodevelopmental impairments.

Previous studies of mostly term newborn infants have demonstrated that initial resuscitation with room air compared to 100% oxygen resulted in improved outcomes and an overall decrease in mortality. The analysis of these studies demonstrated that the reduction in mortality was very significant in the preterm infants that had been included in these trials. A number of small clinical trials have now demonstrated that it is feasible to treat very preterm infants with lower versus higher concentrations of oxygen while carefully monitoring their oxygen saturation in the minutes following delivery. As review of the previous observations demonstrated that there was a reduction in death using lower oxygen concentration, it is imperative that a large study of preterm infants be conducted to determine if a lower compared to a higher oxygen concentration for the initial resuscitation will lead to improved short and longer term outcomes including survival without neurodevelopmental disability.

The PRESOX trial will randomize infants from 23 weeks gestation to 28 weeks gestation who require resuscitation at birth to receive either room air or 60% oxygen. Oxygen saturation will be monitored from the first minute of life and the initial oxygen concentration will be titrated using a unique purpose built device which will track the oxygen saturation (SpO2) within the chosen target limits. The targets chosen allow the infants oxygen saturation to follow the increase seen in normal preterm infants who do not require resuscitation. Following resuscitation the infants will be transferred to the Neonatal Intensive Care Unit and management will follow the usual care in those units. In a subset of infants, levels of antioxidants from the infant's blood and urine will be measured by Dr M Vento. This portion of the study is already funded by the combined Spanish Ministries of Health and Science. Antioxidants are known to increase with exposure to oxygen. The infants will return for a neurodevelopmental follow up examination at the age of two years.

This trial will provide urgently needed evidence to establish the most optimal care to these very fragile preterm infants.

Eligibility criteria: Inclusion Criteria:

Infants with a gestational age of 23 0/7 to 28 6/7 weeks by best obstetrical estimate.

Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation Infants whose parents/legal guardians have provided consent for enrollment, or for whom a waiver of consent is in place Infants without known major congenital malformations prior to delivery

Exclusion Criteria:

Any infant transported to the center after delivery Infants whose parents/legal guardians refuse consent Infants born when the research apparatus/study personnel are not available Infants \< 23 weeks 0 days or \> 28 weeks 6 days, completed weeks of gestation

Primary outcomes:
measure: Survival with neurodevelopmental impairment
timeFrame: 18-22 mos.
Secondary outcomes:
measure: Survival without bronchopulmonary dysplasia
timeFrame: 36 weeks
measure: Survival without ROP
timeFrame: 36 weeks
measure: Decreased GSSG/GSH Ratio
timeFrame: Birth,1,3,7 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Farmington
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: OU - Tulsa - Saint Francis Hospital
state: Oklahoma
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Toulouse
country: France
facility: Chu-Toulouse
city: Ulm
country: Germany
facility: Ulm University
city: Dublin
country: Ireland
facility: National Maternity Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Sienna
country: Italy
facility: University of Siena
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: St. Petersberg
country: Russian Federation
facility: St. Petersberg State Pediatric Medical University
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Saint Joan de Deu
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital La Fe
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: UCSD Medical Center
name: Neil N Finer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Fe, Valencia Spain
name: Maximo Vento, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The National Hospital, Oslo Norway
name: Ola D Saugstad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: