CompletedNCT00233324SUPPORTUpdated Apr 18, 2019Results posted

Surfactant Positive Airway Pressure and Pulse Oximetry Trial

A Phase 3 interventional study of Surfactant and Continuous Positive Airway Pressure (CPAP) in Infant, Newborn, Diseases, Other Preterm Infants and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Completed at 22 sites in United States. Open to participants aged 24 Weeks to 27 Weeks. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by NICHD Neonatal Research Network · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,316
Allocation: Randomized
Ages: 24 Weeks to 27 Weeks
Sex: All

Study summary

This study compared 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, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.

Read the detailed description

Study subjects were 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) were enrolled because more than 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 excluded 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. Secondary studies included: neuroimaging/MRI, growth, and breathing outcomes.

Strata: There were 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 was stratified by gestational age group, occurred prior to delivery for consented deliveries, and was performed by utilizing specially prepared double-sealed envelopes. Deliveries were randomized as a unit, thus multiples, twins, triplets, etc. were randomized to the same arm of the trial.

Informed Consent:

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

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

Pulse Oximeter Allocation:

Infants were randomized to receive either a high- or low-saturation of peripheral oxygen (SpO2) as monitored by a 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 Neuroimaging/MRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development. Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone (DHEA) to: (a) blood pressure and adiposity; (b) prenatal and postnatal growth; and (c) DNA methylation patterns.

Conditions studied

Infant, Newborn, Diseases
Other Preterm Infants
Infant, Small for Gestational Age
Premature Birth
Bronchopulmonary Dysplasia
Retinopathy of Prematurity

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Keywords

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

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 1,316 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 24 Weeks to 27 Weeks
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 1,316 participants (actual)

Study arms

Experimental
Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Drug: Surfactant · Drug: Supplemental oxygen with target saturation of 85 to 89%
Experimental
Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
Drug: Surfactant · Drug: Supplemental oxygen with target saturation of 91 to 95%
Experimental
CPAP and Low Oxygen
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Device: Continuous Positive Airway Pressure (CPAP) · Drug: Supplemental oxygen with target saturation of 85 to 89%
Experimental
CPAP and High Oxygen
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Device: Continuous Positive Airway Pressure (CPAP) · Drug: Supplemental oxygen with target saturation of 91 to 95%

Interventions

DrugSurfactant
Intubation and administration of surfactant by 1 hour of age.
DeviceContinuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Also known as: CPAP
DrugSupplemental oxygen with target saturation of 85 to 89%
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
Also known as: Low oxygen
DrugSupplemental oxygen with target saturation of 91 to 95%
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Also known as: High oxygen

What researchers measure

Primary outcomes

Survival Without Bronchopulmonary Dysplasia (BPD)
Time frame: 36 weeks
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
Time frame: 55 weeks

Secondary outcomes

Death or Neurodevelopmental Impairment
Time frame: 18-22 months
Duration of Mechanical Ventilation
The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.
Time frame: Entire NICU stay, up to 120 days
Survival Without Ventilation
Surviving the first 7 days of life without any need for ventilation by day 7
Time frame: From birth through first 7 days of life.
Received Surfactant Treatment
Received any surfactant treatment.
Time frame: From birth through 120 days of life.
Number of Participants With Air Leaks
Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.
Time frame: From birth through first 14 days of life.
Physiological Bronchopulmonary Dysplasia
Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (\<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen \<27% and had majority saturation \>90%, or they were receiving effective oxygen 27-30% and had majority saturation \>96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.
Time frame: 36 weeks post menstrual age.
Death
Participants who died by their follow-up visit at 18-22 months.
Time frame: 18-22 months
Severe Intraventricular Hemorrhage (IVH)
There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.
Time frame: From birth through first 120 days of life.
Periventricular Leukomalacia (PVL)
Increased echogenicity or cysts in periventricular region.
Time frame: From birth through first 120 days of life.
Threshold Retinopathy of Prematurity (ROP) Requiring Surgery
Diagnosis of retinopathy of prematurity which resulted in requiring surgery.
Time frame: From birth through first 120 days of life.
Endotracheal Intubation
Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
Time frame: Delivery Room, post-delivery
Duration of Oxygen Supplementation
The length of time in days that a participant had oxygen supplementation.
Time frame: From birth through first 120 days of life.
Pulse Oximetry Values > 90%
Percentage of time spent above 90% oxygen saturation.
Time frame: From birth through first 120 days of life.
Blindness in at Least One Eye
Blindness in at least one eye by 18-22 months of life.
Time frame: 18-22 months
Received Postnatal Steroids
Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.
Time frame: From birth through first 120 days of life.
Necrotizing Enterocolitis (NEC)
Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.
Time frame: From birth through first 120 days of life.
Cerebral Palsy
Incidence of cerebral palsy.
Time frame: 18-22 months

Other outcomes

Apgar Scores at 5 Minutes
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth.
Time frame: 5 minutes after birth.

Results

Posted Dec 5, 2014

Participant flow

3546 infants assessed for eligibility from 3127 pregnancies. 2230 were excluded for not meeting eligibility criteria or parental permission was not granted or other reasons.

Main Study

Participant flow — Main Study
Milestone	Early Surfactant and Lower Range Oxygen	Early Surfactant and Higher Range Oxygen	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen
Started	318	335	336	327
Completed	250	275	274	280
Not completed	68	60	62	47
Withdrew: Death	68	60	62	47

Follow up at 18-22 Months Corrected Age

Participant flow — Follow up at 18-22 Months Corrected Age
Milestone	Early Surfactant and Lower Range Oxygen	Early Surfactant and Higher Range Oxygen	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen
Started	250	275	274	280
Completed	237	261	256	269
Not completed	13	14	18	11
Withdrew: Death	5	7	5	4
Withdrew: Undetermined retinopathy status	8	7	13	7

Outcome measures

PrimarySurvival Without Bronchopulmonary Dysplasia (BPD)

Time frame:: 36 weeks
Reported as:: Number · Participants

Survival Without Bronchopulmonary Dysplasia (BPD)
Participants	CPAP	Surfactant
Survival Without Bronchopulmonary Dysplasia (BPD)	346	320

PrimarySurvival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)

Time frame:: 55 weeks
Reported as:: Number · participants

Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
participants	Lower Oxygen Saturation Target	Higher Oxygen Saturation Target
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)	434	418

SecondaryDeath or Neurodevelopmental Impairment

Time frame:: 18-22 months
Reported as:: Number · participants

Death or Neurodevelopmental Impairment
participants	CPAP	Surfactant	Lower Oxygen Saturation Target	Higher Oxygen Saturation Target
Death or Neurodevelopmental Impairment	173	183	185	171

SecondaryDuration of Mechanical Ventilation

The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.

Time frame:: Entire NICU stay, up to 120 days
Reported as:: Median · days

Duration of Mechanical Ventilation
days	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Duration of Mechanical Ventilation	11 (2 to 32)	13 (2 to 37)	7 (1 to 29)	11.5 (2 to 32.5)

SecondarySurvival Without Ventilation

Surviving the first 7 days of life without any need for ventilation by day 7

Time frame:: From birth through first 7 days of life.
Reported as:: Count of participants · Participants

Survival Without Ventilation
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Survival Without Ventilation	161	157	190	172

SecondaryReceived Surfactant Treatment

Received any surfactant treatment.

Time frame:: From birth through 120 days of life.
Reported as:: Count of participants · Participants

Received Surfactant Treatment
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Received Surfactant Treatment	159	176	42	51

SecondaryNumber of Participants With Air Leaks

Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.

Time frame:: From birth through first 14 days of life.
Reported as:: Count of participants · Participants

Number of Participants With Air Leaks
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Number of Participants With Air Leaks	26	22	25	20

SecondaryPhysiological Bronchopulmonary Dysplasia

Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (\<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen \<27% and had majority saturation \>90%, or they were receiving effective oxygen 27-30% and had majority saturation \>96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.

Time frame:: 36 weeks post menstrual age.
Reported as:: Count of participants · Participants

Physiological Bronchopulmonary Dysplasia
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Physiological Bronchopulmonary Dysplasia	102	117	103	120

SecondaryDeath

Participants who died by their follow-up visit at 18-22 months.

Time frame:: 18-22 months
Reported as:: Count of participants · Participants

Death
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Death	73	67	67	51

SecondarySevere Intraventricular Hemorrhage (IVH)

There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.

Time frame:: From birth through first 120 days of life.
Reported as:: Count of participants · Participants

Severe Intraventricular Hemorrhage (IVH)
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Severe Intraventricular Hemorrhage (IVH)	34	38	49	43

SecondaryPeriventricular Leukomalacia (PVL)

Increased echogenicity or cysts in periventricular region.

Time frame:: From birth through first 120 days of life.
Reported as:: Count of participants · Participants

Periventricular Leukomalacia (PVL)
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Periventricular Leukomalacia (PVL)	10	16	14	14

SecondaryThreshold Retinopathy of Prematurity (ROP) Requiring Surgery

Diagnosis of retinopathy of prematurity which resulted in requiring surgery.

Time frame:: From birth through first 120 days of life.
Reported as:: Count of participants · Participants

Threshold Retinopathy of Prematurity (ROP) Requiring Surgery
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Threshold Retinopathy of Prematurity (ROP) Requiring Surgery	19	44	17	47

SecondaryEndotracheal Intubation

Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.

Time frame:: Delivery Room, post-delivery
Reported as:: Count of participants · Participants

Endotracheal Intubation
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Endotracheal Intubation	294	315	110	117

SecondaryDuration of Oxygen Supplementation

The length of time in days that a participant had oxygen supplementation.

Time frame:: From birth through first 120 days of life.
Reported as:: Median · days

Duration of Oxygen Supplementation
days	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Duration of Oxygen Supplementation	46 (21 to 87)	60 (33 to 93)	43 (15 to 71)	59 (28.5 to 88)

SecondaryPulse Oximetry Values > 90%

Percentage of time spent above 90% oxygen saturation.

Time frame:: From birth through first 120 days of life.
Reported as:: Median · percentage of time

Pulse Oximetry Values > 90%
percentage of time	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Pulse Oximetry Values > 90%	62 (53 to 73)	76 (70 to 81)	63 (55 to 73)	77 (71 to 83)

SecondaryBlindness in at Least One Eye

Blindness in at least one eye by 18-22 months of life.

Time frame:: 18-22 months
Reported as:: Count of participants · Participants

Blindness in at Least One Eye
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Blindness in at Least One Eye	4	3	1	5

SecondaryReceived Postnatal Steroids

Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.

Time frame:: From birth through first 120 days of life.
Reported as:: Count of participants · Participants

Received Postnatal Steroids
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Received Postnatal Steroids	42	41	19	28

SecondaryNecrotizing Enterocolitis (NEC)

Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.

Time frame:: From birth through first 120 days of life.
Reported as:: Count of participants · Participants

Necrotizing Enterocolitis (NEC)
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Necrotizing Enterocolitis (NEC)	36	27	40	43

SecondaryCerebral Palsy

Incidence of cerebral palsy.

Time frame:: 18-22 months
Reported as:: Count of participants · Participants

Cerebral Palsy
Participants	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Cerebral Palsy	17	17	26	24

Other pre-specifiedApgar Scores at 5 Minutes

Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth.

Time frame:: 5 minutes after birth.
Reported as:: Median · scores on a scale

Apgar Scores at 5 Minutes
scores on a scale	Surfactant and Low Oxygen	Surfactant and High Oxygen	CPAP and Low Oxygen	CPAP and High Oxygen
Apgar Scores at 5 Minutes	7 (6 to 8)	7 (6 to 8)	7 (6 to 8)	7 (6 to 8)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Surfactant and Lower Range Oxygen	—	204/318 (64.2%)	4/318 (1.3%)
Surfactant and Higher Range Oxygen	—	227/335 (67.8%)	5/335 (1.5%)
CPAP and Lower Range Oxygen	—	231/336 (68.8%)	11/336 (3.3%)
CPAP and Higher Range Oxygen	—	224/327 (68.5%)	7/327 (2.1%)

Most frequent serious events

Most frequent serious events
Event	Surfactant and Lower Range Oxygen	Surfactant and Higher Range Oxygen	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen
Patent Ductus AretriosusCardiac disorders	151/311	160/325	156/330	164/323
DeathGeneral disorders	68/318	60/335	62/336	47/327
Intraventricular hemorrhage (IVH) Grade 3 or 4Nervous system disorders	34/307	38/321	49/323	43/319
Necrotizing enterocolitisGastrointestinal disorders	36/311	27/325	40/330	43/324
Air leak during initial 14 daysRespiratory, thoracic and mediastinal disorders	26/318	22/335	25/336	20/327
Pulmonary HemorrhageRespiratory, thoracic and mediastinal disorders	24/311	21/325	20/330	13/324
Chest compressions or drugs in the delivery roomCardiac disorders	22/318	24/335	19/333	17/327
Nasal BreakdownRespiratory, thoracic and mediastinal disorders	0/318	1/335	0/336	1/327

Most frequent other events

Most frequent other events
Event	Surfactant and Lower Range Oxygen	Surfactant and Higher Range Oxygen	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen
Nasal BreakdownRespiratory, thoracic and mediastinal disorders	4/318	3/335	10/336	6/327
Any other non-serious adverse eventGeneral disorders	0/318	2/335	1/336	1/327

Baseline characteristics

Age, Customized
Age, Customized(participants)	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen	Early Surfactant and Lower Range Oxygen	Early Surfactant and Higher Range Oxygen	Total
>23 weeks and <28 weeks gestational age	336	327	318	335	1316

Sex: Female, Male
Sex: Female, Male(Participants)	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen	Early Surfactant and Lower Range Oxygen	Early Surfactant and Higher Range Oxygen	Total
Female	172	149	141	142	604
Male	164	178	177	193	712

Region of Enrollment
Region of Enrollment(participants)	CPAP and Lower Range Oxygen	CPAP and Higher Range Oxygen	Early Surfactant and Lower Range Oxygen	Early Surfactant and Higher Range Oxygen	Total
United States	336	327	318	335	1316

Study locations

22 sites

University of Alabama at Birmingham
Birmingham, Alabama 35233, United States
Stanford University
Palo Alto, California 94304, United States
University of California at San Diego
San Diego, California 92103-8774, United States
Yale University
New Haven, Connecticut 06504, United States
University of Miami
Miami, Florida 33136, United States
Emory University
Atlanta, Georgia 30303, United States
Indiana University
Indianapolis, Indiana 46202, United States
University of Iowa
Iowa City, Iowa 52242, United States
Tufts Medical Center
Boston, Massachusetts 02111, United States
Wayne State University
Detroit, Michigan 48201, United States
University of New Mexico
Albuquerque, New Mexico 87131, United States
University of Rochester
Rochester, New York 14642, United States
Wake Forest University
Charlotte, North Carolina 27157, United States
RTI International
Durham, North Carolina 27705, United States
Duke University
Durham, North Carolina 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island 02905, United States
University of Tennessee
Memphis, Tennessee 38163, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas 77030, United States
University of Utah
Salt Lake City, Utah 84108, United States

References and documents

Publications

Deuticke B. Monocarboxylate transport in red blood cells: kinetics and chemical modification. Methods Enzymol. 1989;173:300-29. doi: 10.1016/s0076-6879(89)73020-2. No abstract available. PubMed 2674614 ↗
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16. PubMed 20472937 ↗
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235. PubMed 20472939 ↗
Rich WD, Auten KJ, Gantz MG, Hale EC, Hensman AM, Newman NS, Finer NN; National Institute of Child Health and Human Development Neonatal Research Network. Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010 Jul;126(1):e215-21. doi: 10.1542/peds.2009-3353. Epub 2010 Jun 29. PubMed 20587676 ↗
Di Fiore JM, Walsh M, Wrage L, Rich W, Finer N, Carlo WA, Martin RJ; SUPPORT Study Group of Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Low oxygen saturation target range is associated with increased incidence of intermittent hypoxemia. J Pediatr. 2012 Dec;161(6):1047-52. doi: 10.1016/j.jpeds.2012.05.046. Epub 2012 Jun 26. PubMed 22738947 ↗
Rich W, Finer NN, Gantz MG, Newman NS, Hensman AM, Hale EC, Auten KJ, Schibler K, Faix RG, Laptook AR, Yoder BA, Das A, Shankaran S; SUPPORT and Generic Database Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Enrollment of extremely low birth weight infants in a clinical research study may not be representative. Pediatrics. 2012 Mar;129(3):480-4. doi: 10.1542/peds.2011-2121. Epub 2012 Feb 27. PubMed 22371462 ↗
Ambalavanan N, Carlo WA, Wrage LA, Das A, Laughon M, Cotten CM, Kennedy KA, Laptook AR, Shankaran S, Walsh MC, Higgins RD; SUPPORT Study Group of the NICHD Neonatal Research Network. PaCO2 in surfactant, positive pressure, and oxygenation randomised trial (SUPPORT). Arch Dis Child Fetal Neonatal Ed. 2015 Mar;100(2):F145-9. doi: 10.1136/archdischild-2014-306802. Epub 2014 Nov 25. PubMed 25425651 ↗
Navarrete CT, Wrage LA, Carlo WA, Walsh MC, Rich W, Gantz MG, Das A, Schibler K, Newman NS, Piazza AJ, Poindexter BB, Shankaran S, Sanchez PJ, Morris BH, Frantz ID 3rd, Van Meurs KP, Cotten CM, Ehrenkranz RA, Bell EF, Watterberg KL, Higgins RD, Duara S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Growth Outcomes of Preterm Infants Exposed to Different Oxygen Saturation Target Ranges from Birth. J Pediatr. 2016 Sep;176:62-68.e4. doi: 10.1016/j.jpeds.2016.05.070. Epub 2016 Jun 22. PubMed 27344218 ↗
Stevens TP, Finer NN, Carlo WA, Szilagyi PG, Phelps DL, Walsh MC, Gantz MG, Laptook AR, Yoder BA, Faix RG, Newman JE, Das A, Do BT, Schibler K, Rich W, Newman NS, Ehrenkranz RA, Peralta-Carcelen M, Vohr BR, Wilson-Costello DE, Yolton K, Heyne RJ, Evans PW, Vaucher YE, Adams-Chapman I, McGowan EC, Bodnar A, Pappas A, Hintz SR, Acarregui MJ, Fuller J, Goldstein RF, Bauer CR, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT). J Pediatr. 2014 Aug;165(2):240-249.e4. doi: 10.1016/j.jpeds.2014.02.054. Epub 2014 Apr 13. PubMed 24725582 ↗
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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00233324
Lead sponsor: NICHD Neonatal Research Network
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: Oct 5, 2005
Start date: Feb 2005
Primary completion: Feb 2009
Completion: Aug 2016
Results posted: Dec 5, 2014
Last update: Apr 18, 2019

Study contacts

Abbot R. Laptook, MD

principal investigator · Brown University, Women & Infants Hospital of Rhode Island

Michele C. Walsh, MD MS

principal investigator · Case Western Reserve University, Rainbow Babies and Children's Hospital

Ronald N. Goldberg, MD

principal investigator · Duke University

Barbara J. Stoll, MD

principal investigator · Emory University

Brenda B. Poindexter, MD MS

principal investigator · Indiana University

Abhik Das, PhD

principal investigator · RTI International

Krisa P. Van Meurs, MD

principal investigator · Stanford University

Ivan D. Frantz III, MD

principal investigator · Tufts Medical Center

Neil N. Finer, MD

principal investigator · University of California, San Diego

Kurt Schibler, MD

principal investigator · Children's Hospital Medical Center, Cincinnati

Waldemar A. Carlo, MD

principal investigator · University of Alabama at Birmingham

Edward F. Bell, MD

principal investigator · University of Iowa

Kristi L. Watterberg, MD

principal investigator · University of New Mexico

Pablo J. Sanchez, MD

principal investigator · University of Texas, Southwestern Medical Center at Dallas

Kathleen A. Kennedy, MD MPH

principal investigator · The University of Texas Health Science Center, Houston

Roger G. Faix, MD

principal investigator · University of Utah

Seetha Shankaran, MD

principal investigator · Wayne State University

Richard A. Ehrenkranz, MD

principal investigator · Yale University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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