Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807235

Enrollment

Registered

2008-12-11

Start date

2005-01-31

Completion date

2005-09-30

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature

Brief summary

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Detailed description

Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Interventions

DRUGAerosolized lucinactant

Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Minutes to 30 Minutes

Healthy volunteers

Inclusion criteria

* Gestational age 28-32 completed weeks, inclusive * Placement of arterial line * Successful initiation of nCPAP * Informed Consent

Exclusion criteria

* Heart rate that cannot be stabilized \>100 bpm within 5 minutes of birth * Five (5) minute Apgar score ≤ 3 * Major congenital malformation(s) diagnosed antenatally or noted immediately after birth * Other disease(s) or conditions potentially interfering with cardiopulmonary function * Mother with prolonged rupture of membranes \> 2 weeks * Known or suspected chromosomal abnormality * Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room * Need for mechanical ventilation within 30 minutes of birth

Design outcomes

Primary

Measure	Time frame
Number of Participants With Respiratory Distress Syndrome	24 hours

Secondary

Measure	Time frame	Description
Arterial Alveolar (a/A) O₂Ratio	72 hours	a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.
Time to Meet Failure Criteria	Through 28 days	Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Number of Participants With Bronchopulmonary Dysplasia (BPD)	28 days	—
Number of Participants Alive and Without BPD	28 days	—
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)	28 days	—
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)	0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours	AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Number of Participants With Necrotizing Enterocolitis (NEC)	28 days	—
Number of Participants With Pulmonary Hemorrhage	28 days	—
Number of Participants With Acquired Sepsis	28 days	—
Incidence of Mortality	28 days	—
Number of Participants With Air Leak	28 days	—
Number of Participants With Patent Ductus Arteriosus (PDA)	28 days	—

Countries

United States

Participant flow

Recruitment details

Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).

Participants by arm

Arm	Count
Lucinactant - 3 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours	11
Lucinactant - 1 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour	6
Total	17

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0

Baseline characteristics

Characteristic	Total	Lucinactant - 1 Hour Interval	Lucinactant - 3 Hour Interval
Age, Categorical <=18 years	17 Participants	6 Participants	11 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Gestational Age	30.1 weeks STANDARD_DEVIATION 1.31	30.7 weeks STANDARD_DEVIATION 0.99	29.8 weeks STANDARD_DEVIATION 1.4
Region of Enrollment United States	17 participants	6 participants	11 participants
Sex: Female, Male Female	9 Participants	2 Participants	7 Participants
Sex: Female, Male Male	8 Participants	4 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	11 / 11	6 / 6
serious Total, serious adverse events	5 / 11	1 / 6