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

Phase 2

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Drug: Lucinactant for Inhalation; Device: nCPAP alone

• Registration Number: NCT02074059
• Lead Sponsor: Windtree Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Results First Submitted: 2016-12-21
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-10
• Last Update Submitted: 2017-03-10
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Aerosolized lucinactant (25 mg/kg)	Lucinactant for Inhalation	25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP
Aerosolized lucinactant (150 mg/kg)	Lucinactant for Inhalation	150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.
Aerosolized lucinactant (50 mg/kg)	Lucinactant for Inhalation	50 mg TPL/kg: Lucinactant for inhalation with nCPAP
nCPAP alone	nCPAP alone	nCPAP therapy alone
Aerosolized lucinactant (75 mg/kg)	Lucinactant for Inhalation	75 mg TPL/kg: Lucinactant for inhalation with nCPAP
Aerosolized lucinactant (100 mg/kg)	Lucinactant for Inhalation	100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

Primary Outcome Measures

Name	Time	Method
Peri-Dosing Events	Within 48 Hours after Initiation of Study Treatment	Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone
All Cause Mortality	Within 36 Weeks PMA
Serum Electrolytes	24 Hours Post Randomization
Oxygen Saturation Levels	Within 3 Hours of Randomization	Oxygen saturation as determined by pulse oximetry

Secondary Outcome Measures

Name	Time	Method
PCO2	Within 3 Hours of Randomization	Arterial carbon dioxide

Trial Locations

Locations (11)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Riley Hospital for Children at IU Health; 🇺🇸 Indianapolis, Indiana, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

Mid Atlantic Neonatology Associates; 🇺🇸 Morristown, New Jersey, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Providence St. Vincent Medical Center; 🇺🇸 Portland, Oregon, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States