Sustained Aeration of Infant Lungs Trial

Preterm Birth Clinical Trial

— SAIL  

Official title:

Sustained Aeration of Infant Lungs Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139800
• Other study ID #: 819208
• Secondary ID: 1U01HD072906-01A
• Status: Completed
• Phase: N/A
• Start date: August 27, 2014
• Est. completion date: March 23, 2020

Study information

• Verified date: April 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: March 23, 2020
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 26 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Extreme Prematurity
• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
Australia	Mater Mother's Hospital	Brisbane	Queensland
Australia	Royal Women's Hospital	Melbourne
Austria	Academic Teaching Hospital, Landeskrankenhaus Feldkirch	Feldkirch
Canada	Royal Alexandra Hospital,	Edmonton
Germany	University of Freiburg	Freiburg
Germany	Children's Hospital, University of Ulm	Ulm
Italy	Ospedale dei Bambini	Milan
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Children's Hospit	Seoul
Netherlands	Emma Children's Hospital, AMC	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Singapore	KK Women's and Children's Hospital	Singapore
United States	University of Michigan	Ann Arbor	Michigan
United States	Loma Linda University	Loma Linda	California
United States	Christiana Care	Newark	Delaware
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	Wake Med Health	Raleigh	North Carolina
United States	University of California, Davis Children's Hospital	Sacramento	California
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygen Profile Over First 24 Hours	Oxygen profile over first 24 hours post delivery room using hourly FiO2 records	First 24 hours post delivery
Secondary	Oxygen Profile With Highest FiO2 Level up to 48 Hours	Highest FiO2 level recorded during the first 48 hours post DR	48 hours of life
Secondary	Heart Rate in the Delivery Room (DR)	Categorical variable with 3 levels: <60, 60-100, >100	First 30 seconds of life in DR
Secondary	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	Resuscitation time will vary - 1 to 30 minutes
Secondary	Use of Inotropes on Arrival in NICU	Circulatory support post-delivery room	First 48 hours of life
Secondary	Need for Intubation in Delivery Room	Need for intubation in delivery room during the first 30 seconds to 24 hours of age	First 30 seconds to 24 hours of life
Secondary	Pressure-volume Characteristics in the Delivery Room (DR)	Pressure-volume characteristics in the Delivery room (DR) expected within 30 minutes	Expected average 30 minutes
Secondary	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	First 48 hours of life
Secondary	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)	During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	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	48 hours to 10 days
Secondary	Chest X-ray Between Days 7-10	Chest x-ray between the first 7-10 days of life	First 7-10 days of life
Secondary	Death or Need for Positive Pressure Ventilation	Death or need for positive pressure ventilation during the first 7 days of life	First 7 days of life
Secondary	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	First 7 days of life
Secondary	Pneumothorax and Pulmonary Interstitial Emphysema (PIE)	Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life	First 10 days of life
Secondary	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	Expected discharge between 36 - 40 weeks PMA
Secondary	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)	During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	Death in Hospital	Death in hospital during expected hospitalization of 23-40 weeks PMA	During expected hospitalization 23 - 40 weeks PMA
Secondary	Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment	Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment at 36 weeks	36 weeks
Secondary	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)	During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	Length of Hospital Stay	Length of hospital stay with average discharge between 36-40 weeks PMA	Average discharge between 36 - 40 weeks PMA
Secondary	Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age	Neurodevelopmental and respiratory outcome at 22-26 months corrected gestational age	22-26 months corrected gestational age