Skip to main content
OpenTrials
Completed

NCT Number: NCT02139800

Sustained Aeration of Infant Lungs Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Birth Extreme Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–26 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mater Mother's Hospital, Brisbane, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sustained Inflation

Procedure

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

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

Primary outcomes

  1. 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 outcomes

  1. Oxygen Profile Over First 24 Hours

    Time frame: First 24 hours post delivery

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

  2. 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

  3. 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

  4. 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

  5. Use of Inotropes on Arrival in NICU

    Time frame: First 48 hours of life

    Circulatory support post-delivery room

  6. Need for Intubation in Delivery Room

    Time frame: First 30 seconds to 24 hours of life

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

  7. Pressure-volume Characteristics in the Delivery Room (DR)

    Time frame: Expected average 30 minutes

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

  8. Pneumothorax or New Chest Drains in the First 48 Hours of Life

    Time frame: First 48 hours of life

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

  9. Duration of Any Chest Drain In-situ Post-DR

    Time frame: 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)

  10. Intraventricular Hemorrhage by All Grades

    Time frame: 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

  11. Chest X-ray Between Days 7-10

    Time frame: First 7-10 days of life

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

  12. Death or Need for Positive Pressure Ventilation

    Time frame: First 7 days of life

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

  13. Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life

    Time frame: First 7 days of life

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

  14. Pneumothorax and Pulmonary Interstitial Emphysema (PIE)

    Time frame: First 10 days of life

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

  15. 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

    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

  16. Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen)

    Time frame: 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)

  17. Death in Hospital

    Time frame: During expected hospitalization 23 - 40 weeks PMA

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

  18. Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment

    Time frame: 36 weeks

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

  19. Use of Postnatal Steroids for Treatment of BPD

    Time frame: 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)

  20. Length of Hospital Stay

    Time frame: Average discharge between 36 - 40 weeks PMA

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

  21. Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age

    Time frame: 22-26 months corrected gestational age

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: SAIL

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
May 15, 2014
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.