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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074059
• Other study ID #: 03-CL-1201
• Secondary ID: 4R44HL107000-02
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2014
• Last updated: November 19, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Discovery Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Weeks to 34 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Lucinactant for Inhalation
Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)

Device:
• nCPAP alone
nCPAP therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Discovery Laboratories, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of Lucinactant for Inhalation	Assessed during dosing by recording adverse reactions, oxygen saturation levels, and serum electrolytes; and following dosing by recording complications of prematurity and signs of worsening respiratory distress as evidenced by need for increased respiratory support and supplemental oxygen	Day 7	Yes