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

NCT ID: NCT00767039

Last Updated: 2011-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

Detailed 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.

Conditions

Prematurity; Respiratory Distress Syndrome; Patent Ductus Arteriosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Survanta (beractant)

Intervention Type: DRUG

beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)

2

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

Group Type: EXPERIMENTAL

Curosurf (poractant)

Intervention Type: DRUG

poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)

Interventions

Survanta (beractant)

beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)

Intervention Type: DRUG

Curosurf (poractant)

poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)

Intervention Type: DRUG

Other Intervention Names

Survanta; Curosurf

Eligibility Criteria

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

• Maximum Eligible Age: 8 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dey LP

UNKNOWN

Sponsor Role: collaborator

Alan Fujii

OTHER

Sponsor Role: lead

Responsible Party

Alan Fujii

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alan M Fujii, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Fujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90

Reference Type: BACKGROUND

Fujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51.

Reference Type: BACKGROUND

Fujii AM, Carillo M. Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 10.1358/dot.2009.45.9.1418185.

Reference Type: RESULT

PMID: 19956811 (View on PubMed)

Fujii AM, Patel SM, Allen R, Doros G, Guo CY, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25.

Reference Type: RESULT

PMID: 20336076 (View on PubMed)

Fujii A, Allen R, Doros G, O'Brien S. Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):671-6. doi: 10.1038/jp.2010.21. Epub 2010 Mar 25.

Reference Type: RESULT

PMID: 20336077 (View on PubMed)

Fujii AM, Bailey J, Doros G, Sampat K, Sikes NC, Mason M, Kaiser JR. Cerebral Blood Flow Responses to Beractant and Poractant Administration. Journal of Neonatal-Perinatal Medicine 2009; 2:27-34

Reference Type: RESULT

Other Identifiers

H-23371

Identifier Type: -

Identifier Source: org_study_id