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

NCT01773746 | Terminated DMC

• 1 other identifier: 2012-3602
• Study Type: interventional
• Target: 80
• Locations: 12 countries
• Sites: 22

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.

Conditions

Extreme Prematurity - Less Than 28 Weeks

Keywords

neonatal; resuscitation; room air

Outcome Measures

Primary Outcomes (1)

• Survival with neurodevelopmental impairment

  To determine if resuscitation starting with 21% oxygen and a targeted SpO2 strategy will increase survival without significant neurodevelopmental impairment at 18 to 22 months when compared with starting with 60% oxygen and a targeted SpO2 strategy.

  18-22 mos.

Secondary Outcomes (3)

• Survival without bronchopulmonary dysplasia

  36 weeks

• Survival without ROP

  36 weeks

• Decreased GSSG/GSH Ratio

  Birth,1,3,7 days

Study Arms (2)

Room Air

ACTIVE COMPARATOR

Neonatal Resuscitation using continuous positive airway pressure(CPAP) or positive pressure ventilation (PPV) will be provided with 21% oxygen. Infants will remain on 21% oxygen until they have a functioning oximeter when SpO2 will be managed as below. FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range.

Other: Neonatal Resuscitation

60% Group

ACTIVE COMPARATOR

Neonatal Resuscitation using CPAP or PPV will be provided with 60% oxygen. Infants will remain on 60% oxygen until they have a functioning oximeter at which time their SpO2 will be managed as described below FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range.

Other: Neonatal Resuscitation

Interventions

Neonatal Resuscitation OTHER

CPAP or Positive Pressure Ventilation will be provided.

60% Group; Room Air

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead
• Thrasher Research Fund: collaborator

Study Sites (22)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Connecticut Children's Medical Center

Farmington, Connecticut, 06030-2948, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33101, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

OU - Tulsa - Saint Francis Hospital

Tulsa, Oklahoma, 74135, United States

Location

Innsbruck Medical University

Innsbruck, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Chu-Toulouse

Toulouse, France

Location

Ulm University

Ulm, Germany

Location

National Maternity Hospital

Dublin, Ireland

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

University of Siena

Siena, Italy

Location

Poznan University of Medical Sciences

Poznan, Poland

Location

St. Petersberg State Pediatric Medical University

Saint Petersberg, Russia

Location

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Saint Joan de Deu

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Karolinska Institutet

Stockholm, Sweden

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Study Officials

• Neil N Finer, MD

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

• Maximo Vento, MD

  Hospital La Fe, Valencia Spain

  PRINCIPAL INVESTIGATOR

• Ola D Saugstad, MD, PhD

  The National Hospital, Oslo Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Consultant

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 23, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

US (6); IE (1); SE (1); RU (1); IT (2); PL (1); DE (1); ES (4); GB (1); AU (2); FR (1); SL (1)