Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome

In brief

The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

Key facts

Study ID

NCT02074059

Run by

Windtree Therapeutics

People needed

80

Starts

2014-02-01

Expected to finish

2015-11-01

Last updated by the study team

2017-04-21

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent from a legally authorized representative
• Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
• Successful implementation of controlled nCPAP within 90 minutes after birth
• Spontaneous breathing
• Chest radiograph consistent with RDS
• Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

You may not qualify if…

• Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
• Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
• A 5 minute Apgar score < 5
• Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
• Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
• Known or suspected chromosomal abnormality or syndrome
• Prolong rupture of membranes (PROM) > 2 weeks
• Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
• Need for endotracheal intubation and mechanical ventilation
• Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Miami — Miami, Florida, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Mid Atlantic Neonatology Associates — Morristown, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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