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Trial record 1 of 1 for:    02139800
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Sustained Aeration of Infant Lungs Trial (SAIL)

This study is currently recruiting participants.
Verified March 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT02139800
First Posted: May 15, 2014
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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

Condition Intervention
Preterm Birth Extreme Prematurity Procedure: Sustained Inflation Procedure: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustained Aeration of Infant Lungs Trial

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Oxygen profile over first 24 hours post delivery room using hourly FiO2 records [ Time Frame: First 24 hours post delivery ]
  • Oxygen profile with highest FiO2 level up to 48 hours [ Time Frame: 48 hours of life ]
    Highest FiO2 level recorded during the first 48 hours post DR

  • Heart rate in the Delivery Room (DR) [ Time Frame: First 30 seconds of life in DR ]
    Categorical variable with 3 levels: <60, 60-100, >100

  • Detailed status on departure from the Delivery room (DR) [ Time Frame: Resuscitation time will vary - 1 to 30 minutes ]
    Type of respiratory support (CPAP, PPV) and Fraction of Inspired Oxygen (FiO2) on departure from DR

  • Use of inotropes on arrival in NICU [ Time Frame: First 48 hours of life ]
    Circulatory support post-delivery room

  • Need for intubation in delivery room or by 24 hours of age [ Time Frame: First 30 seconds to 24 hours of life ]
  • Pressure-volume characteristics in the Delivery room (DR) [ Time Frame: Expected average 30 minutes ]
  • Chest x-ray reports showing 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) ]
  • 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 [ 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 at 7 days [ 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 ]

Estimated Enrollment: 600
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: 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
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
Procedure: Sustained Inflation
The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 26 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139800


Contacts
Contact: Haresh Kirpalani, BM,MSc 215-590-2455 kirpalanih@email.chop.edu
Contact: Sarah J Ratcliffe, PhD 215-573-7398 sratclif@upenn.edu

  Show 22 Study Locations
Sponsors and Collaborators
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02139800     History of Changes
Other Study ID Numbers: 819208
1U01HD072906-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 8, 2014
First Posted: May 15, 2014
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Pennsylvania:
Neonatal resuscitation
Extreme Low Gestational Age Newborn (ELGAN)
Delivery Room
Continuous positive airway pressure (CPAP)
Positive pressure ventilation (PPV)
Sustained inflation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications