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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02139800




Registration number
NCT02139800
Ethics application status
Date submitted
8/05/2014
Date registered
15/05/2014
Date last updated
6/04/2023

Titles & IDs
Public title
Sustained Aeration of Infant Lungs Trial
Scientific title
Sustained Aeration of Infant Lungs Trial
Secondary ID [1] 0 0
1U01HD072906-01A1
Secondary ID [2] 0 0
819208
Universal Trial Number (UTN)
Trial acronym
SAIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 0 0
Extreme Prematurity 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Sustained Inflation
Treatment: Surgery - Standard of Care

Active comparator: 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

Experimental: 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


Treatment: Surgery: Sustained Inflation
The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds

Treatment: Surgery: 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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined Outcome of Death or Bronchopulmonary Dysplasia
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
Oxygen Profile Over First 24 Hours
Timepoint [1] 0 0
First 24 hours post delivery
Secondary outcome [2] 0 0
Oxygen Profile With Highest FiO2 Level up to 48 Hours
Timepoint [2] 0 0
48 hours of life
Secondary outcome [3] 0 0
Heart Rate in the Delivery Room (DR)
Timepoint [3] 0 0
First 30 seconds of life in DR
Secondary outcome [4] 0 0
Detailed Status on Departure From the Delivery Room (DR)
Timepoint [4] 0 0
Resuscitation time will vary - 1 to 30 minutes
Secondary outcome [5] 0 0
Use of Inotropes on Arrival in NICU
Timepoint [5] 0 0
First 48 hours of life
Secondary outcome [6] 0 0
Need for Intubation in Delivery Room
Timepoint [6] 0 0
First 30 seconds to 24 hours of life
Secondary outcome [7] 0 0
Pressure-volume Characteristics in the Delivery Room (DR)
Timepoint [7] 0 0
Expected average 30 minutes
Secondary outcome [8] 0 0
Pneumothorax or New Chest Drains in the First 48 Hours of Life
Timepoint [8] 0 0
First 48 hours of life
Secondary outcome [9] 0 0
Duration of Any Chest Drain In-situ Post-DR
Timepoint [9] 0 0
During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary outcome [10] 0 0
Intraventricular Hemorrhage by All Grades
Timepoint [10] 0 0
48 hours to 10 days
Secondary outcome [11] 0 0
Chest X-ray Between Days 7-10
Timepoint [11] 0 0
First 7-10 days of life
Secondary outcome [12] 0 0
Death or Need for Positive Pressure Ventilation
Timepoint [12] 0 0
First 7 days of life
Secondary outcome [13] 0 0
Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life
Timepoint [13] 0 0
First 7 days of life
Secondary outcome [14] 0 0
Pneumothorax and Pulmonary Interstitial Emphysema (PIE)
Timepoint [14] 0 0
First 10 days of life
Secondary outcome [15] 0 0
Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound
Timepoint [15] 0 0
Expected discharge between 36 - 40 weeks PMA
Secondary outcome [16] 0 0
Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen)
Timepoint [16] 0 0
During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary outcome [17] 0 0
Death in Hospital
Timepoint [17] 0 0
During expected hospitalization 23 - 40 weeks PMA
Secondary outcome [18] 0 0
Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment
Timepoint [18] 0 0
36 weeks
Secondary outcome [19] 0 0
Use of Postnatal Steroids for Treatment of BPD
Timepoint [19] 0 0
During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary outcome [20] 0 0
Length of Hospital Stay
Timepoint [20] 0 0
Average discharge between 36 - 40 weeks PMA
Secondary outcome [21] 0 0
Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age
Timepoint [21] 0 0
22-26 months corrected gestational age

Eligibility
Key inclusion criteria
* 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)
Minimum age
23 Weeks
Maximum age
26 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2020
Sample size
Target
Accrual to date
Final
460
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Mother's Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
QLD 4101 - Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
Austria
State/province [7] 0 0
Feldkirch
Country [8] 0 0
Canada
State/province [8] 0 0
Edmonton
Country [9] 0 0
Germany
State/province [9] 0 0
Freiburg
Country [10] 0 0
Germany
State/province [10] 0 0
Ulm
Country [11] 0 0
Italy
State/province [11] 0 0
Milan
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Netherlands
State/province [13] 0 0
Amsterdam
Country [14] 0 0
Netherlands
State/province [14] 0 0
Leiden
Country [15] 0 0
Singapore
State/province [15] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pennsylvania
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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:

1. 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
2. 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
Trial website
https://clinicaltrials.gov/study/NCT02139800
Trial related presentations / publications
Foglia 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.
Kirpalani 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.
Kirpalani 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.
Foglia 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.
Foglia 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.
Public notes

Contacts
Principal investigator
Name 0 0
Haresh Kirpalani, BM, MSc
Address 0 0
Children's Hospital of Philadelphia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02139800