Clinical trial NCT02074059: Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Official title: A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 29 to 34 Weeks PMA: Dose Escalation and Study Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 29
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential escalating dosing groups, each group contained an active and control arm of equal size.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peri-Dosing Events
timeFrame: Within 48 Hours after Initiation of Study Treatment
measure: All Cause Mortality
timeFrame: Within 36 Weeks PMA
measure: Oxygen Saturation Levels
timeFrame: Within 3 Hours of Randomization
measure: Serum Electrolytes
timeFrame: 24 Hours Post Randomization
Secondary outcomes:
measure: PCO2
timeFrame: Within 3 Hours of Randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Morristown
country: United States
facility: Mid Atlantic Neonatology Associates
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
Study officials:
affiliation: Windtree Therapeutics, Inc.
name: Robert Segal, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: