Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

Alan Fujii

Status and phase: Terminated; Phase 4

Conditions: Prematurity; Respiratory Distress Syndrome; Patent Ductus Arteriosus

Treatments: Drug: Curosurf (poractant); Drug: Survanta (beractant)

Study type: Interventional

Funder types: Other

Identifiers

NCT00767039

H-23371

Details and patient eligibility

About

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates.

The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

Full description

Specific Aims:

• To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta
• To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta
• To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta
• To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta

We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.

Enrollment: 52 patients

Sex: All

Ages: Under 8 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <29 6/7 and >24 0/7 weeks gestational age
• Inborn at the participating institution enrolling the patient
• FIO2 >25% and Intubated with mean airway pressure > 5 cm H20
• <8 hours age at randomization
• Signed informed consent from parent(s)

Exclusion criteria

• <500 g birth weight
• <24 0/7 weeks gestational age (best estimate)
• Prolonged Premature Rupture of membranes >3 weeks (21 days)
• Apgar score < 3 at 5 minutes
• Impending death anticipated within the first 3 days of life, moribund
• Severe congenital anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Active Comparator group

Description:

Surfactant (beractant, Survanta initial dose 100 mg/kg and subsequent doses 100 mg/kg phospholipids every 6-12 hours, as needed for up to 4 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation

Treatment:

Drug: Survanta (beractant)

2

Experimental group

Description:

Surfactant (poractant, Curosurf initial dose 200 mg/kg and subsequent doses 100 mg/kg phospholipids every 12-24 hours as needed for up to 3 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation

Treatment:

Drug: Curosurf (poractant)