Trial Outcomes & Findings for Surfactant Positive Airway Pressure and Pulse Oximetry Trial (NCT NCT00233324)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1316 participants

Primary outcome timeframe

36 weeks

Results posted on

2019-04-18

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.

235 did not meet eligiblity criteria 125 did not have personnel or equipment available 699 were eligible did not have consent sought 344 were eligible but parent or guardian was not available 748 were eligible but parent or guardian denied permission to enroll 68 were eligible and had permission but were not randomized 11 had other reasons

Participant milestones

Participant milestones
Measure	Early Surfactant and Lower Range Oxygen Early Surfactant and 85-89% target oxygen saturation	Early Surfactant and Higher Range Oxygen Early Surfactant and 91-95% target oxygen saturation	CPAP and Lower Range Oxygen Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation	CPAP and Higher Range Oxygen Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
Main Study STARTED	318	335	336	327
Main Study COMPLETED	250	275	274	280
Main Study NOT COMPLETED	68	60	62	47
Follow up at 18-22 Months Corrected Age STARTED	250	275	274	280
Follow up at 18-22 Months Corrected Age COMPLETED	237	261	256	269
Follow up at 18-22 Months Corrected Age NOT COMPLETED	13	14	18	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Surfactant and Lower Range Oxygen Early Surfactant and 85-89% target oxygen saturation	Early Surfactant and Higher Range Oxygen Early Surfactant and 91-95% target oxygen saturation	CPAP and Lower Range Oxygen Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation	CPAP and Higher Range Oxygen Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
Main Study Death	68	60	62	47
Follow up at 18-22 Months Corrected Age Death	5	7	5	4
Follow up at 18-22 Months Corrected Age Undetermined retinopathy status	8	7	13	7

Baseline Characteristics

Surfactant Positive Airway Pressure and Pulse Oximetry Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP and Lower Range Oxygen n=336 Participants Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)	CPAP and Higher Range Oxygen n=327 Participants Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)	Early Surfactant and Lower Range Oxygen n=318 Participants Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)	Early Surfactant and Higher Range Oxygen n=335 Participants Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)	Total n=1316 Participants Total of all reporting groups
Age, Customized >23 weeks and <28 weeks gestational age	336 participants n=39 Participants	327 participants n=41 Participants	318 participants n=35 Participants	335 participants n=31 Participants	1316 participants n=146 Participants
Sex: Female, Male Female	172 Participants n=39 Participants	149 Participants n=41 Participants	141 Participants n=35 Participants	142 Participants n=31 Participants	604 Participants n=146 Participants
Sex: Female, Male Male	164 Participants n=39 Participants	178 Participants n=41 Participants	177 Participants n=35 Participants	193 Participants n=31 Participants	712 Participants n=146 Participants
Region of Enrollment United States	336 participants n=39 Participants	327 participants n=41 Participants	318 participants n=35 Participants	335 participants n=31 Participants	1316 participants n=146 Participants

PRIMARY outcome

Timeframe: 36 weeks

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=663 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=653 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Survival Without Bronchopulmonary Dysplasia (BPD)	—	346 Participants	320 Participants	—

PRIMARY outcome

Timeframe: 55 weeks

Population: 49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=605 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=616 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)	—	434 participants	418 participants	—

SECONDARY outcome

Timeframe: 18-22 months

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=622 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=621 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=613 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=612 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Death or Neurodevelopmental Impairment	171 participants	173 participants	183 participants	185 participants

SECONDARY outcome

Timeframe: Entire NICU stay, up to 120 days

Population: 1078 participants survived to discharge and they all had information available for regarding use of mechanical ventilation.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=280 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=249 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=275 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=274 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Duration of Mechanical Ventilation	11.5 days Interval 2.0 to 32.5	11 days Interval 2.0 to 32.0	13 days Interval 2.0 to 37.0	7 days Interval 1.0 to 29.0

SECONDARY outcome

Timeframe: From birth through first 7 days of life.

Population: 1307 participants had known survival and ventilation statuses. 9 participants were excluded due to unknown ventilation status from birth through 7 days of life: 6 infants in the lower oxygen group, 3 infants in the high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=324 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=317 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=335 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=331 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Survival Without Ventilation	172 Participants	161 Participants	157 Participants	190 Participants

SECONDARY outcome

Timeframe: From birth through 120 days of life.

Population: 1312 participants had known surfactant treatment. 4 were excluded due to unknown surfactant treatment: 2 infants in the low oxygen group, 2 infants in the high oxygen group.

Received any surfactant treatment.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=325 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=317 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=335 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=335 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Received Surfactant Treatment	51 Participants	159 Participants	176 Participants	42 Participants

SECONDARY outcome

Timeframe: From birth through first 14 days of life.

Population: All 1316 participants had data on incidence of air leaks.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=327 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=318 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=335 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=336 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Number of Participants With Air Leaks	20 Participants	26 Participants	22 Participants	25 Participants

SECONDARY outcome

Timeframe: 36 weeks post menstrual age.

Population: 1108 participants survived to 36 weeks and had BPD information. 208 participants did not survive to 36 weeks and were excluded: 114 from the low oxygen group, 94 from the high oxygen group.

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.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=287 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=258 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=281 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=282 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Physiological Bronchopulmonary Dysplasia	120 Participants	102 Participants	117 Participants	103 Participants

SECONDARY outcome

Timeframe: 18-22 months

Population: 1281 participants with confirmed deaths or survivals by follow-up. 35 were excluded due to incomplete follow-up visits: 21 in low oxygen group, 14 in high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=320 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=310 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=328 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=323 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Death	51 Participants	73 Participants	67 Participants	67 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 1270 participants had known IVH grades. 46 were excluded due to unknown IVH status: 24 infants from the low oxygen group, 22 infants from high oxygen group.

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.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=319 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=307 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=321 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=323 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Severe Intraventricular Hemorrhage (IVH)	43 Participants	34 Participants	38 Participants	49 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 1272 participants had known PVL statuses. 44 were excluded due to unknown PVL status: 23 infants in the low oxygen group, 21 infants in the high oxygen group.

Increased echogenicity or cysts in periventricular region.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=319 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=307 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=322 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=324 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Periventricular Leukomalacia (PVL)	14 Participants	10 Participants	16 Participants	14 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 997 surviving participants with ROP data were included. 319 total participants were excluded due to death (N=224) or missing ROP data (N=95): 171 in the low oxygen group, 148 in the high oxygen group.

Diagnosis of retinopathy of prematurity which resulted in requiring surgery.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=264 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=230 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=250 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=253 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Threshold Retinopathy of Prematurity (ROP) Requiring Surgery	47 Participants	19 Participants	44 Participants	17 Participants

SECONDARY outcome

Timeframe: Delivery Room, post-delivery

Population: 1312 participants had non-missing data on whether they experienced endotracheal intubation. 4 participants were excluded due to missing information: 2 infants in the low oxygen group, 2 infants in the high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=325 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=317 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=335 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=335 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Endotracheal Intubation	117 Participants	294 Participants	315 Participants	110 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 1078 participants survived to discharge and they all had information available regarding the duration of their oxygen supplementation.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=280 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=249 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=275 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=274 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Duration of Oxygen Supplementation	59 days Interval 28.5 to 88.0	46 days Interval 21.0 to 87.0	60 days Interval 33.0 to 93.0	43 days Interval 15.0 to 71.0

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 90 were excluded due to incomplete data: 48 from the low oxygen saturation group and 42 from the high oxygen saturation group.

Percentage of time spent above 90% oxygen saturation.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=306 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=302 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=314 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=304 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Pulse Oximetry Values > 90%	77 percentage of time Interval 71.0 to 83.0	62 percentage of time Interval 53.0 to 73.0	76 percentage of time Interval 70.0 to 81.0	63 percentage of time Interval 55.0 to 73.0

SECONDARY outcome

Timeframe: 18-22 months

Population: 990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=257 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=225 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=254 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=254 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Blindness in at Least One Eye	5 Participants	4 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 1280 participants had information regarding whether they received postnatal steroids. 36 participants were excluded due to missing data: 18 infants in the low oxygen group, 18 infants in the high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=321 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=308 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=323 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=328 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Received Postnatal Steroids	28 Participants	42 Participants	41 Participants	19 Participants

SECONDARY outcome

Timeframe: From birth through first 120 days of life.

Population: 1290 participants had known NEC statuses. 26 were excluded due to missing NEC data: 13 infants in the low oxygen group, 13 infants in the high oxygen group.

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

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=324 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=311 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=325 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=330 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Necrotizing Enterocolitis (NEC)	43 Participants	36 Participants	27 Participants	40 Participants

SECONDARY outcome

Timeframe: 18-22 months

Population: 990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.

Incidence of cerebral palsy.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=257 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=225 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=254 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=254 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Cerebral Palsy	24 Participants	17 Participants	17 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes after birth.

Population: All 1316 participants had 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.

Outcome measures

Outcome measures
Measure	CPAP and High Oxygen n=327 Participants Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Surfactant and Low Oxygen n=318 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Surfactant and High Oxygen n=335 Participants Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%	CPAP and Low Oxygen n=336 Participants Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Apgar Scores at 5 Minutes	7 scores on a scale Interval 6.0 to 8.0	7 scores on a scale Interval 6.0 to 8.0	7 scores on a scale Interval 6.0 to 8.0	7 scores on a scale Interval 6.0 to 8.0

Adverse Events

Surfactant and Lower Range Oxygen

Serious events: 204 serious events

Other events: 4 other events

Deaths: 0 deaths

Surfactant and Higher Range Oxygen

Serious events: 227 serious events

Other events: 5 other events

Deaths: 0 deaths

CPAP and Lower Range Oxygen

Serious events: 231 serious events

Other events: 11 other events

Deaths: 0 deaths

CPAP and Higher Range Oxygen

Serious events: 224 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Surfactant and Lower Range Oxygen n=318 participants at risk Early Surfactant and 85-89% target oxygen saturation	Surfactant and Higher Range Oxygen n=335 participants at risk Early Surfactant and 91-95% target oxygen saturation	CPAP and Lower Range Oxygen n=336 participants at risk Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation	CPAP and Higher Range Oxygen n=327 participants at risk Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
General disorders Death	21.4% 68/318	17.9% 60/335	18.5% 62/336	14.4% 47/327
Cardiac disorders Chest compressions or drugs in the delivery room	6.9% 22/318	7.2% 24/335	5.7% 19/333	5.2% 17/327
Respiratory, thoracic and mediastinal disorders Air leak during initial 14 days	8.2% 26/318	6.6% 22/335	7.4% 25/336	6.1% 20/327
Nervous system disorders Intraventricular hemorrhage (IVH) Grade 3 or 4	11.1% 34/307	11.8% 38/321	15.2% 49/323	13.5% 43/319
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	7.7% 24/311	6.5% 21/325	6.1% 20/330	4.0% 13/324
Gastrointestinal disorders Necrotizing enterocolitis	11.6% 36/311	8.3% 27/325	12.1% 40/330	13.3% 43/324
Cardiac disorders Patent Ductus Aretriosus	48.6% 151/311	49.2% 160/325	47.3% 156/330	50.8% 164/323
Respiratory, thoracic and mediastinal disorders Nasal Breakdown	0.00% 0/318	0.30% 1/335	0.00% 0/336	0.31% 1/327

Other adverse events

Other adverse events
Measure	Surfactant and Lower Range Oxygen n=318 participants at risk Early Surfactant and 85-89% target oxygen saturation	Surfactant and Higher Range Oxygen n=335 participants at risk Early Surfactant and 91-95% target oxygen saturation	CPAP and Lower Range Oxygen n=336 participants at risk Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation	CPAP and Higher Range Oxygen n=327 participants at risk Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
Respiratory, thoracic and mediastinal disorders Nasal Breakdown	1.3% 4/318	0.90% 3/335	3.0% 10/336	1.8% 6/327
General disorders Any other non-serious adverse event	0.00% 0/318	0.60% 2/335	0.30% 1/336	0.31% 1/327

Additional Information

Waldemar A. Carlo, M.D

University of Alabama

Phone: (205) 934-4680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place