Preterm BirthSAILNCT02139800
Sustained Aeration of Infant Lungs Trial
A study testing Sustained Inflation in people with Preterm Birth and Extreme Prematurity, run by University of Pennsylvania at 21 sites in 9 countries.
Trial summary
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung… Read more about this study
- Who is it for?
- Ages 23 to 26 weeks
- Conditions the study is for
- Preterm Birth, Extreme Prematurity
- What is being tested?
- Sustained Inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 27 Aug 2014to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 26 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
- Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)
Who cannot join
- Considered non-viable by the attending neonatologist
- Refusal of antenatal informed consent
- Known major anomalies, pulmonary hypoplasia
- Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Loma Linda University
Loma Linda, California, 92354
Christiana Care
Newark, Delaware, 19713
Hospital of the Univerity of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Wake Med Health
Raleigh, North Carolina, 27610
University of California, Davis Children's Hospital
Sacramento, California, 95817
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Australia2 sites
Mater Mother's Hospital
Brisbane, Queensland, QLD 4101
Royal Women's Hospital
Melbourne
Germany2 sites
University of Freiburg
Freiburg im Breisgau
Children's Hospital, University of Ulm
Ulm
Netherlands2 sites
Emma Children's Hospital, AMC
Amsterdam
Leiden University Medical Center
Leiden
South Korea2 sites
Seoul National University Children's Hospit
Seoul, 03080
Samsung Medical Center
Seoul
Austria1 site
Academic Teaching Hospital, Landeskrankenhaus Feldkirch
Feldkirch
About this study
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.
Hypotheses:
- Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
- A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP
Read the detailed description
The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) <1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood.
The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.
- Conditions
- Preterm Birth, Extreme Prematurity
- Being tested
- Sustained Inflation, Standard of Care
- Keywords
- Neonatal resuscitation, Extreme Low Gestational Age Newborn (ELGAN), Delivery Room, Continuous positive airway pressure (CPAP), Positive pressure ventilation (PPV), Sustained inflation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained InflationProcedure or surgery
The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds
Standard of CareProcedure or surgery
Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
| Study group | Role | What they receive |
|---|---|---|
| Control Arm-Standard of care | Active comparator | 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 Receives: Procedure: Standard of Care |
| Sustained Intervention | Experimental | 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 Receives: Procedure: Sustained Inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Outcome of Death or Bronchopulmonary Dysplasia
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.
Measured: 36 weeks
Secondary outcomes (21)
Oxygen Profile Over First 24 Hours
Oxygen profile over first 24 hours post delivery room using hourly FiO2 records
Measured: First 24 hours post delivery
Oxygen Profile With Highest FiO2 Level up to 48 Hours
Highest FiO2 level recorded during the first 48 hours post DR
Measured: 48 hours of life
Heart Rate in the Delivery Room (DR)
Categorical variable with 3 levels: <60, 60-100, >100
Measured: First 30 seconds of life in DR
Detailed Status on Departure From the Delivery Room (DR)
Type of respiratory support (CPAP, PPV) and Fraction of Inspired Oxygen (FiO2) on departure from DR
Measured: Resuscitation time will vary - 1 to 30 minutes
Use of Inotropes on Arrival in NICU
Circulatory support post-delivery room
Measured: First 48 hours of life
Need for Intubation in Delivery Room
Need for intubation in delivery room during the first 30 seconds to 24 hours of age
Measured: First 30 seconds to 24 hours of life
Pressure-volume Characteristics in the Delivery Room (DR)
Pressure-volume characteristics in the Delivery room (DR) expected within 30 minutes
Measured: Expected average 30 minutes
Pneumothorax or New Chest Drains in the First 48 Hours of Life
Chest x-ray reports showing pneumothorax or new chest drains in the first 48 hours of life
Measured: First 48 hours of life
Duration of Any Chest Drain In-situ Post-DR
Duration of any chest drain in-situ post-DR during hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Intraventricular Hemorrhage by All Grades
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
Measured: 48 hours to 10 days
Chest X-ray Between Days 7-10
Chest x-ray between the first 7-10 days of life
Measured: First 7-10 days of life
Death or Need for Positive Pressure Ventilation
Death or need for positive pressure ventilation during the first 7 days of life
Measured: First 7 days of life
Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life
Highest FiO2 and Area under the FiO2 curve during the first 7 days of life
Measured: First 7 days of life
Pneumothorax and Pulmonary Interstitial Emphysema (PIE)
Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life
Measured: First 10 days of life
Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound
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
Measured: Expected discharge between 36 - 40 weeks PMA
Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen)
Duration of respiratory support (ventilation, CPAP, supplemental oxygen) during hospitalization upto 36 weeks Post Menstrual Age (PMA)
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in Hospital
Death in hospital during expected hospitalization of 23-40 weeks PMA
Measured: During expected hospitalization 23 - 40 weeks PMA
Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment
Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment at 36 weeks
Measured: 36 weeks
Use of Postnatal Steroids for Treatment of BPD
Use of postnatal steroids for treatment of BPD during hospitalization up to 36 weeks Post Menstrual Age (PMA)
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Length of Hospital Stay
Length of hospital stay with average discharge between 36-40 weeks PMA
Measured: Average discharge between 36 - 40 weeks PMA
Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age
Neurodevelopmental and respiratory outcome at 22-26 months corrected gestational age
Measured: 22-26 months corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start27 Aug 2014
- Primary completion15 Feb 2018
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Haresh Kirpalani, BM, MSc, Principal investigator, Children's Hospital of PhiladelphiaPeter Davis, MD, FRAXP, Principal investigator, Royal Women's Hospital, Melbourne, AustraliaHelmut Hummler, MD, Principal investigator, Children's Hospital, University of Ulm, Ulm GermanyMartin Keszler, MD, Principal investigator, Women & Infants Hospital of Rhode Island, Providence, RIGianLuca Lista, MD, Principal investigator, Ospedale dei Bambini, Milan ItalyArjan te_Pas, MD, Principal investigator, Leiden University Medical Center, Leiden, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139800
- Sponsor's protocol ID
- 819208
- Other IDs
- 1U01HD072906-01A1
- Acronym
- SAIL
- Status last verified
- Apr 2023
- First submitted
- 8 May 2014
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Owen LS, Foglia EE, Ratcliffe SJ, Simma B, Katheria AC, Te Pas A, Onland W, van Kaam AH, Keszler M, Kirpalani H, Davis PG. Alternative consent processes in a neonatal resuscitation trial (SAIL): secondary analysis of an open-label, international, multicentre, randomised trial. Lancet Child Adolesc Health. 2025 Oct;9(10):698-706. doi: 10.1016/S2352-4642(25)00185-3. Epub 2025 Aug 12.
PubMed 40816312Foglia EE, Kirpalani H, Ratcliffe SJ, Davis PG, Thio M, Hummler H, Lista G, Cavigioli F, Schmolzer GM, Keszler M, Te Pas AB. Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements. J Pediatr. 2021 Dec;239:150-154.e1. doi: 10.1016/j.jpeds.2021.08.038. Epub 2021 Aug 25.
PubMed 34453917Kirpalani H, Keszler M, Foglia EE, Davis P, Ratcliffe S. Considering the Validity of the SAIL Trial-A Navel Gazers Guide to the SAIL Trial. Front Pediatr. 2019 Nov 27;7:495. doi: 10.3389/fped.2019.00495. eCollection 2019.
PubMed 31828052Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660.
PubMed 30912836Foglia EE, Te Pas AB. Sustained Lung Inflation: Physiology and Practice. Clin Perinatol. 2016 Dec;43(4):633-646. doi: 10.1016/j.clp.2016.07.002.
PubMed 27837749Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9.
PubMed 25872563
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Aeration of Infant Lungs Trial
- ClinicalTrials.gov ID
- NCT02139800
- Acronym / sponsor ID
- SAIL / 819208
- Conditions
- Preterm Birth, Extreme Prematurity
- Keywords
- Neonatal resuscitation, Extreme Low Gestational Age Newborn (ELGAN), Delivery Room, Continuous positive airway pressure (CPAP), Positive pressure ventilation (PPV), Sustained inflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 Aug 2014 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.
Hypotheses:
- Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
- A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP
Detailed description
The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) <1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood.
The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm-Standard of care | Active comparator | Procedure: Standard of CareControl 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 |
| Sustained Intervention | Experimental | Procedure: Sustained InflationAdminister delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O |
Who may qualify
- Ages
- 23 to 26 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
- Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)
Key exclusion criteria (4 listed)
- Considered non-viable by the attending neonatologist
- Refusal of antenatal informed consent
- Known major anomalies, pulmonary hypoplasia
- Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained InflationThe first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds | Procedure or surgery | Sustained Intervention |
| Standard of CareNewborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention | Procedure or surgery | Control Arm-Standard of care |
Primary outcome
Combined Outcome of Death or Bronchopulmonary Dysplasia
Time frame: 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.
21 secondary outcomes
Oxygen Profile Over First 24 Hours
Time frame: First 24 hours post delivery
Oxygen Profile With Highest FiO2 Level up to 48 Hours
Time frame: 48 hours of life
Heart Rate in the Delivery Room (DR)
Time frame: First 30 seconds of life in DR
Detailed Status on Departure From the Delivery Room (DR)
Time frame: Resuscitation time will vary - 1 to 30 minutes
Use of Inotropes on Arrival in NICU
Time frame: First 48 hours of life
Need for Intubation in Delivery Room
Time frame: First 30 seconds to 24 hours of life
Pressure-volume Characteristics in the Delivery Room (DR)
Time frame: Expected average 30 minutes
Pneumothorax or New Chest Drains in the First 48 Hours of Life
Time frame: First 48 hours of life
Duration of Any Chest Drain In-situ Post-DR
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Intraventricular Hemorrhage by All Grades
Time frame: 48 hours to 10 days
Chest X-ray Between Days 7-10
Time frame: First 7-10 days of life
Death or Need for Positive Pressure Ventilation
Time frame: First 7 days of life
Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life
Time frame: First 7 days of life
Pneumothorax and Pulmonary Interstitial Emphysema (PIE)
Time frame: First 10 days of life
Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound
Time frame: Expected discharge between 36 - 40 weeks PMA
Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen)
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in Hospital
Time frame: During expected hospitalization 23 - 40 weeks PMA
Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment
Time frame: 36 weeks
Use of Postnatal Steroids for Treatment of BPD
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Length of Hospital Stay
Time frame: Average discharge between 36 - 40 weeks PMA
Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age
Time frame: 22-26 months corrected gestational age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40816312Owen LS, Foglia EE, Ratcliffe SJ, Simma B, Katheria AC, Te Pas A, Onland W, van Kaam AH, Keszler M, Kirpalani H, Davis PG. Alternative consent processes in a neonatal resuscitation trial (SAIL): secondary analysis of an open-label, international, multicentre, randomised trial. Lancet Child Adolesc Health. 2025 Oct;9(10):698-706. doi: 10.1016/S2352-4642(25)00185-3. Epub 2025 Aug 12.
- Derived from this study: PubMed 34453917Foglia EE, Kirpalani H, Ratcliffe SJ, Davis PG, Thio M, Hummler H, Lista G, Cavigioli F, Schmolzer GM, Keszler M, Te Pas AB. Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements. J Pediatr. 2021 Dec;239:150-154.e1. doi: 10.1016/j.jpeds.2021.08.038. Epub 2021 Aug 25.
- Derived from this study: PubMed 31828052Kirpalani H, Keszler M, Foglia EE, Davis P, Ratcliffe S. Considering the Validity of the SAIL Trial-A Navel Gazers Guide to the SAIL Trial. Front Pediatr. 2019 Nov 27;7:495. doi: 10.3389/fped.2019.00495. eCollection 2019.
- Derived from this study: PubMed 30912836Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660.
- Derived from this study: PubMed 27837749Foglia EE, Te Pas AB. Sustained Lung Inflation: Physiology and Practice. Clin Perinatol. 2016 Dec;43(4):633-646. doi: 10.1016/j.clp.2016.07.002.
- Derived from this study: PubMed 25872563Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haresh Kirpalani, BM, MSc principal investigator
Children's Hospital of Philadelphia
Peter Davis, MD, FRAXP principal investigator
Royal Women's Hospital, Melbourne, Australia
Helmut Hummler, MD principal investigator
Children's Hospital, University of Ulm, Ulm Germany
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Inflation in people with Preterm Birth and Extreme Prematurity, run by University of Pennsylvania at 21 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia, Germany, Netherlands, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Outcome of Death or Bronchopulmonary Dysplasia (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139800, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.