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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds
Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
Loma Linda University
Loma Linda, California, United States
University of California, Davis Children's Hospital
Sacramento, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Christiana Care
Newark, Delaware, United States
University of Michigan
Ann Arbor, Michigan, United States
Wake Med Health
Raleigh, North Carolina, United States
Hospital of the Univerity of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Mater Mother's Hospital
Brisbane, Queensland, Australia
...and 11 more locations
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.
Time frame: 36 weeks
Oxygen Profile Over First 24 Hours
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
Highest FiO2 level recorded during the first 48 hours post DR
Time frame: 48 hours of life
Heart Rate in the Delivery Room (DR)
Categorical variable with 3 levels: \<60, 60-100, \>100
Time frame: 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
Time frame: Resuscitation time will vary - 1 to 30 minutes
Use of Inotropes on Arrival in NICU
Circulatory support post-delivery room
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 48 hours to 10 days
Chest X-ray Between Days 7-10
Chest x-ray between the first 7-10 days of life
Time frame: 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
Time frame: 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
Time frame: First 7 days of life
Pneumothorax and Pulmonary Interstitial Emphysema (PIE)
Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life
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
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
Time frame: 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)
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in Hospital
Death in hospital during expected hospitalization of 23-40 weeks PMA
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 22-26 months corrected gestational age
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