Sustained Aeration of Infant Lungs Trial

NCT02139800 | Completed Results DMC

• 2 other identifiers: 8192081U01HD072906-01A1
• Study Type: interventional
• Target: 460
• Locations: 8 countries
• Sites: 19

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. 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  36 weeks

Secondary Outcomes (21)

• Oxygen Profile Over First 24 Hours

  First 24 hours post delivery

• Oxygen Profile With Highest FiO2 Level up to 48 Hours

  48 hours of life

• Heart Rate in the Delivery Room (DR)

  First 30 seconds of life in DR

• Detailed Status on Departure From the Delivery Room (DR)

  Resuscitation time will vary - 1 to 30 minutes

• Use of Inotropes on Arrival in NICU

  First 48 hours of life

Study Arms (2)

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

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

Procedure: Sustained Inflation

Interventions

Sustained Inflation PROCEDURE

The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds

Sustained Intervention

Standard of Care PROCEDURE

Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention

Control Arm-Standard of care

Eligibility Criteria

• Age: 23 Weeks - 26 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (21)

Loma Linda University

Loma Linda, California, 92354, United States

Location

University of California, Davis Children's Hospital

Sacramento, California, 95817, United States

Location

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Christiana Care

Newark, Delaware, 19713, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wake Med Health

Raleigh, North Carolina, 27610, United States

Location

Hospital of the Univerity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Mater Mother's Hospital

Brisbane, Queensland, QLD 4101, Australia

Location

Royal Women's Hospital

Melbourne, Australia

Location

Academic Teaching Hospital, Landeskrankenhaus Feldkirch

Feldkirch, Austria

Location

Royal Alexandra Hospital,

Edmonton, Canada

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

Children's Hospital, University of Ulm

Ulm, Germany

Location

Ospedale dei Bambini

Milan, Italy

Location

Emma Children's Hospital, AMC

Amsterdam, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

KK Women's and Children's Hospital

Singapore, 168753, Singapore

Location

Seoul National University Children's Hospit

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (6)

• 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.

  PMID: 40816312 DERIVED

• 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.

  PMID: 34453917 DERIVED

• 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.

  PMID: 31828052 DERIVED

• 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.

  PMID: 30912836 DERIVED

• 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.

  PMID: 27837749 DERIVED

• 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.

  PMID: 25872563 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Haresh Kirpalani
• Organization: Children's Hospital of Philadelphia (CHOP)

kirpalanih@email.chop.edu

215-590-2455

Study Officials

• Haresh Kirpalani, BM, MSc

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Peter Davis, MD, FRAXP

  Royal Women's Hospital, Melbourne, Australia

  PRINCIPAL INVESTIGATOR

• Helmut Hummler, MD

  Children's Hospital, University of Ulm, Ulm Germany

  PRINCIPAL INVESTIGATOR

• Martin Keszler, MD

  Women & Infants Hospital of Rhode Island, Providence, RI

  PRINCIPAL INVESTIGATOR

• GianLuca Lista, MD

  Ospedale dei Bambini, Milan Italy

  PRINCIPAL INVESTIGATOR

• Arjan te_Pas, MD

  Leiden University Medical Center, Leiden, Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 15, 2014
• Study Start: August 27, 2014
• Primary Completion: February 15, 2018
• Study Completion: March 23, 2020
• Last Updated: April 6, 2023
• Results First Posted: June 25, 2020

Record last verified: 2023-04

Locations

SG (1); DE (2); NL (2); KR (2); AU (1); IT (1); US (9); CA (1)