Surfactant Positive Airway Pressure and Pulse Oximetry Trial - Full Text View

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00233324

Purpose

This study will compare the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, will have a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study will determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.

Condition	Intervention	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia Retinopathy of Prematurity Continuous Positive Airway Pressure	Procedure: Early surfactant Procedure: Continuous Positive Airway Pressure (CPAP) Procedure: Target oxygen saturation of 85-89% Procedure: Target oxygen saturation of 91-85%	Phase III

MedlinePlus related topics: Premature Babies Retinal Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Survival without bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Survival without severe Retinopathy of Prematurity (ROP) (threshold disease or the need for surgery) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Apgar score [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
Death or neurodevelopmental impairment [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
Duration of mechanical ventilation [ Time Frame: During entire NICU stay ] [ Designated as safety issue: Yes ]
Survival without ventilation [ Time Frame: By day 7 ] [ Designated as safety issue: Yes ]
Received surfactant treatment [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Incidence of air leaks [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Bronchopulmonary Disease (using the physiologic definition of BPD) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Death [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
Severe intraventricular hemorrhage (IVH) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Periventricular leukomalacia (PVL) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Threshold ROP requiring surgery [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Endotracheal intubation [ Time Frame: Before 10 minutes of age ] [ Designated as safety issue: Yes ]
Duration of oxygen supplementation [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Pulse oximetry values > 90% [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Blindness in at least one eye [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
Received postnatal steroids [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Necrotizing enterocolitis (NEC) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
Cerebral palsy [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1320
Study Start Date:	February 2005
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Early Surfactant and 85-89% target oxygen saturation	Procedure: Early surfactant Intubation and administration of surfactant by 1 hour of age. Procedure: Target oxygen saturation of 85-89% SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
2: Active Comparator Early Surfactant and 91-95% target oxygen saturation	Procedure: Early surfactant Intubation and administration of surfactant by 1 hour of age. Procedure: Target oxygen saturation of 91-85% SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
3: Active Comparator CPAP and 85-89% target oxygen saturation	Procedure: Continuous Positive Airway Pressure (CPAP) Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU Procedure: Target oxygen saturation of 85-89% SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
4: Active Comparator CPAP and 91-95% target oxygen saturation	Procedure: Continuous Positive Airway Pressure (CPAP) Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU Procedure: Target oxygen saturation of 91-85% SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.

Detailed Description:

Study subjects are infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by best obstetric estimate) will be enrolled because over 80% of such infants in the Network are intubated, usually early in their neonatal course. The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50% of such infants if they are not intubated for surfactant. We will exclude infants of 23 weeks or less in view of their extremely high mortality and morbidity, and their almost universal need for delivery room intubation for resuscitation.

Strata: There will be two randomization strata, infants of 24 0/7ths to 25 6/7ths weeks, and infants of 26 0/7ths-27 6/7ths weeks by best obstetrical estimate.

Randomization:

Randomization will be stratified by gestational age group, will occur prior to delivery for consented deliveries, and will be performed by utilizing specially prepared double-sealed envelopes. Deliveries will be randomized as a unit, thus multiples, twins, triplets etc will be randomized to the same arm of the trial.

Informed Consent:

Parents will be approached prior to delivery for informed consent, and their infants enrolled at delivery.

Study Intervention: Mode of Ventilatory Support The intervention will begin after birth when the infant is given to the resuscitation team. The conduct of the resuscitation will follow usual guidelines, and once stabilized, all Control infants in both strata will receive prophylactic/early surfactant (within one hour of age) whereas all Treatment infants will be placed on CPAP/PEEP following stabilization, and be intubated only for resuscitation indications.

Pulse Oximeter Allocation:

The assignment to either a high- or low-saturation of peripheral oxygen (SpO2) study oximeter immediately following NICU admission, with a maximum allowable delay of two hours following admission.

The SUPPORT Trial recruitment was temporarily paused on November 23, 2005 based on concern regarding pulse oximeter readings > 95% and due to concern regarding separation of the two arms of the oximetry portion of the study. Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95%. Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values, which both showed group differences. The trial was restarted on February 6, 2006.

Follow-up: Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment.

Extended follow-up: Subjects enrolled in the MRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development.

Eligibility

Ages Eligible for Study:	24 Weeks to 27 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) 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
Infants without known major congenital malformations

Exclusion Criteria:

Any infant transported to the center after delivery
Infants whose parents/legal guardians refuse consent
Infants born during a time when the research apparatus/study personnel are not available
Infants < 24 weeks 0 days or > 28 weeks 0 days, completed weeks of gestation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233324

Contacts

Contact: Neil N. Finer, MD	619-543-3759	nfiner@ucsd.edu
Contact: Rosemary D. Higgins, MD	301-495-5575	higginsr@mail.nih.gov

Show 22 Study Locations

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Abbot R. Laptook, MD	Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator:	Michele C. Walsh, MD MS	Case Western Reserve University
Principal Investigator:	Ronald N. Goldberg, MD	Duke University
Principal Investigator:	Barbara J. Stoll, MD	Emory University
Principal Investigator:	Brenda B. Poindexter, MD MS	Indiana University
Principal Investigator:	Abhik Das, PhD	RTI International
Principal Investigator:	Krisa P. Van Meurs, MD	Stanford University
Principal Investigator:	Ivan D. Frantz III, MD	Tufts Medical Center
Principal Investigator:	Neil N. Finer, MD	University of California, San Diego
Principal Investigator:	Kurt Schibler, MD	University of Cincinnati
Principal Investigator:	Waldemar A. Carlo, MD	University of Alabama at Birmingham
Principal Investigator:	Edward F. Bell, MD	University of Iowa
Principal Investigator:	Kristi L. Watterberg, MD	University of New Mexico
Principal Investigator:	Pablo J. Sanchez, MD	University of Texas Southwestern Medical Center at Dallas
Principal Investigator:	Kathleen A. Kennedy, MD MPH	The University of Texas Health Science Center, Houston
Principal Investigator:	Roger G. Faix, MD	University of Utah
Principal Investigator:	Seetha Shankaran, MD	Wayne State University
Principal Investigator:	Richard A. Ehrenkranz, MD	Yale University

More Information

NICHD Neonatal Research Network site This link exits the ClinicalTrials.gov site

Publications:

Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7.

Responsible Party:	University of California - San Diego ( Neil N. Finer, Study Principal Investigator )
Study ID Numbers:	NICHD-NRN-0031, U10 HD21364 (Case), U10 HD21373 (UT Houston), U10 HD21385 (Wayne State), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27904 (Brown), U10 HD34216 (Alabama), U10 HD36790 (RTI), U10 HD40461 (UCSD), U10 HD40492 (Duke), U10 HD40689 (UT Dallas), U10 HD53089 (New Mexico), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CCTS KL2 RR24149 (Houston), CCTS UL1 RR24128 (Duke), CCTS UL1 RR24139 (Yale), CCTS UL1 RR24148 (Houston), CCTS UL1 RR24979 (Iowa), CCTS UL1 RR24982 (Dallas), CCTS UL1 RR24989 (Case), CCTS UL1 RR25008 (Emory), GCRC M01 RR30 (Duke), GCRC M01 RR633 (Dallas), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR750 (Indiana), GCRC M01 RR80 (Case), GCRC M01 RR8084 (Cincinnati), Inactive grants:, U10 HD40461 (UCSD), U10 HD21397 (Miami), U10 HD40521 (Rochester), U10 HD40498 (Wake Forest)
Study First Received:	October 3, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00233324
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Prematurity
Mechanical ventilation
Surfactant

Intubation
Neurodevelopmental impairment
Pulse oximetry
Oxygen saturation
Positive-Pressure Respiration

Study placed in the following topic categories:

Birth Weight
Bronchopulmonary dysplasia
Eye Diseases
Retinopathy of prematurity
Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Body Weight

Signs and Symptoms
Respiratory Tract Diseases
Lung Diseases
Infant, Newborn, Diseases
Retinopathy of Prematurity
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009