An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery system (NCPAP PDDS) in infants with respiratory distress syndrome.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-000489-37-CZ
• Date of registration: 19/08/2005
• Prospective Registration: Yes
• Primary sponsor: Nektar Therapeutics
• Public title: An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery system (NCPAP PDDS) in infants with respiratory distress syndrome.
• Scientific title: An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery system (NCPAP PDDS) in infants with respiratory distress syndrome.
• Date of first enrolment: 26/08/2005
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000489-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Observational control

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
Patients who meet all of the following criteria are eligible to participate in the study:

1.RDS by clinical and radiographic criteria
2.Birth weight between and including 750 to 1000 g if gestional age (GA) = 27 weeks, and between 1001 to 2500 g (no restrictions on GA)
3.Post-natal age of 2 to 4h
4.On NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% for = 30 min preceding randomization
5.Arterial line in place
6.At least one ABG obtained while on NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% during the hour prior to randomization
7.Written informed consent obtained from parent or legal guardian prior to enrollment

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients who meet any of the following criteria are not eligible to participate in the study:

1.Rupture of membranes > 6 days prior to delivery
2.Prior surfactant treatment
3.Any post-natal ABG with pH<7.20
4.Any ABG obtained =1h prior to randomization with pH<7.23
5.Pneumothorax, including pneumonthorax which has been successfully evacuated
6.Apgar score = 3 at 5min post-natal age
7.Major congenital anomalies (e.g. CHD, myelomeningocele)
8.Congenital heart disease (does not include patent ductus arteriosus, patent foramen ovale or small ventricular defect)
9.Requiring >10 µg/kg/min dopamine to maintain acceptable blood pressure during the hour prior to randomization
10.Other medical problem that would potentially interfere with the conduct of the study or confound study endpoints
11.Previously received or are planned to receive any other experimental treatment during the study period



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The medical condition for this application is the Respiratory Distress Syndrome (RDS). RDS, also known as hyaline membrane disease, is characterized by lung immaturity and surfactant deficiency and is the most common respiratory disorder in premature infants. The first clinical manifestations of RDS at birth are grunting respiration, subcostal and intercostal retractions, cyanosis and nasal flaring.

Intervention(s)

Trade Name: Curosurf
Product Name: Curosurf
Product Code: N/A
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: Dipalmitoylphosphatidylcholine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: The primary objective is to evaluate the safety of aerosolized Curosurf delivered via nasal continuous positive airway pressure (NCPAP) in infants with RDS.

Primary end point(s): The primary endpoints of the trial are:
- Clinically significant changes in vital signs
- Incidence of treatment related adverse events and serious adverse events
- Change in fraction of inspired oxygen (FiO2)
- Need for Instilled surfactant

Secondary Objective: The secondary objective is to evaluate the efficacy of aerosolized Curosurf delivered via NCPAP in infants with RDS.

Secondary ID(s)

SURF-04-01