Trial Outcomes & Findings for Sustained Aeration of Infant Lungs Trial (NCT NCT02139800)

Results Overview

To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

460 participants

Primary outcome timeframe

36 weeks

Results posted on

2023-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Control Arm-Standard of Care Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention	Sustained Intervention Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds
Overall Study STARTED	224	236
Overall Study COMPLETED	211	215
Overall Study NOT COMPLETED	13	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sustained Aeration of Infant Lungs Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm-Standard of Care n=211 Participants Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention	Sustained Intervention n=215 Participants Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds	Total n=426 Participants Total of all reporting groups
Age, Customized 23-24 weeks GA	75 Participants n=5 Participants	76 Participants n=7 Participants	151 Participants n=5 Participants
Age, Customized 25-26 weeks GA	136 Participants n=5 Participants	139 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	96 Participants n=7 Participants	204 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	119 Participants n=7 Participants	222 Participants n=5 Participants
Race/Ethnicity, Customized White	110 Participants n=5 Participants	148 Participants n=7 Participants	258 Participants n=5 Participants
Race/Ethnicity, Customized Black	50 Participants n=5 Participants	29 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Asian	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Other	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Canada	23 participants n=5 Participants	20 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment Netherlands	50 participants n=5 Participants	56 participants n=7 Participants	106 participants n=5 Participants
Region of Enrollment Austria	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment South Korea	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Singapore	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	66 participants n=7 Participants	127 participants n=5 Participants
Region of Enrollment Italy	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Australia	35 participants n=5 Participants	30 participants n=7 Participants	65 participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants	21 participants n=7 Participants	41 participants n=5 Participants
Consent Type Antenatal	113 participants n=5 Participants	122 participants n=7 Participants	235 participants n=5 Participants
Consent Type Deferred	98 participants n=5 Participants	93 participants n=7 Participants	191 participants n=5 Participants
Maternal Age	30.5 years n=5 Participants	31.1 years n=7 Participants	30.9 years n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia.

Outcome measures

Outcome measures
Measure	Control Arm-Standard of Care n=211 Participants Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention	Sustained Intervention n=215 Participants Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds
Combined Outcome of Death or Bronchopulmonary Dysplasia	125 Participants	137 Participants

SECONDARY outcome

Timeframe: First 24 hours post delivery

Oxygen profile over first 24 hours post delivery room using hourly FiO2 records

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours of life

Highest FiO2 level recorded during the first 48 hours post DR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 30 seconds of life in DR

Categorical variable with 3 levels: \<60, 60-100, \>100

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Resuscitation time will vary - 1 to 30 minutes

Type of respiratory support (CPAP, PPV) and Fraction of Inspired Oxygen (FiO2) on departure from DR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 48 hours of life

Circulatory support post-delivery room

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 30 seconds to 24 hours of life

Need for intubation in delivery room during the first 30 seconds to 24 hours of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Expected average 30 minutes

Pressure-volume characteristics in the Delivery room (DR) expected within 30 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 48 hours of life

Chest x-ray reports showing pneumothorax or new chest drains in the first 48 hours of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)

Duration of any chest drain in-situ post-DR during hospitalization - up to 36 weeks Post Menstrual Age (PMA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours to 10 days

Head ultrasound and/or MRI findings of intraventricular hemorrhage by all grades focusing on grades 3 and 4 by 48 hour and by day 10

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 7-10 days of life

Chest x-ray between the first 7-10 days of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 7 days of life

Death or need for positive pressure ventilation during the first 7 days of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 7 days of life

Highest FiO2 and Area under the FiO2 curve during the first 7 days of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 10 days of life

Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Expected discharge between 36 - 40 weeks PMA

Survival to discharge home without BPD, retinopathy of prematurity (grades 3 \& 4), or significant brain abnormalities on head ultrasound with an expected discharge between 36-40 weeks PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)

Duration of respiratory support (ventilation, CPAP, supplemental oxygen) during hospitalization upto 36 weeks Post Menstrual Age (PMA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During expected hospitalization 23 - 40 weeks PMA

Death in hospital during expected hospitalization of 23-40 weeks PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks

Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment at 36 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)

Use of postnatal steroids for treatment of BPD during hospitalization up to 36 weeks Post Menstrual Age (PMA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Average discharge between 36 - 40 weeks PMA

Length of hospital stay with average discharge between 36-40 weeks PMA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 22-26 months corrected gestational age

Neurodevelopmental and respiratory outcome at 22-26 months corrected gestational age

Outcome measures

Outcome data not reported

Adverse Events

Sustained Intervention

Serious events: 45 serious events

Other events: 157 other events

Deaths: 48 deaths

Control Arm-Standard of Care

Serious events: 51 serious events

Other events: 146 other events

Deaths: 35 deaths

Serious adverse events

Serious adverse events
Measure	Sustained Intervention n=215 participants at risk Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds	Control Arm-Standard of Care n=211 participants at risk Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
Pregnancy, puerperium and perinatal conditions Death	7.4% 16/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	1.4% 3/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Surgical and medical procedures Administration of epinephrine or chest compressions	2.8% 6/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	3.8% 8/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Pregnancy, puerperium and perinatal conditions Pneumothorax	5.1% 11/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	9.0% 19/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Respiratory, thoracic and mediastinal disorders Pulmonary Interstitial Emphysemia (PIE)	3.3% 7/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	2.8% 6/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Pregnancy, puerperium and perinatal conditions Grade 3 or 4 IVH	9.8% 21/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	10.4% 22/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first

Other adverse events

Other adverse events
Measure	Sustained Intervention n=215 participants at risk Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds	Control Arm-Standard of Care n=211 participants at risk Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
Surgical and medical procedures FiO2>=0.4 for >=2 hrs in first 2 DOL	23.3% 50/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	24.6% 52/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Pregnancy, puerperium and perinatal conditions IVH Grade 1/2 within first 10 days of life	23.7% 51/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	20.9% 44/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Surgical and medical procedures >30% oxygen at 28 days of life	30.7% 66/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	36.0% 76/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
Surgical and medical procedures Mechanical support at 28 days of life	39.1% 84/215 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first	43.1% 91/211 • Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first

Additional Information

Dr. Haresh Kirpalani

Children's Hospital of Philadelphia (CHOP)

Phone: 215-590-2455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place