Suspended

CASTPhase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.

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What is being tested

Survanta (beractant)

+ Curosurf (poractant)

Drug
Who is being recruted

Congenital Abnormalities+14

+ Urogenital Diseases

+ Cardiovascular Diseases

+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorAlan Fujii
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.
NCT00767039
Principal SponsorAlan Fujii
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesCardiovascular DiseasesDuctus Arteriosus, PatentFemale Urogenital Diseases and Pregnancy ComplicationsHeart Defects, CongenitalHeart DiseasesObstetric Labor ComplicationsObstetric Labor, PrematureLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsRespiration DisordersRespiratory Distress SyndromeRespiratory Tract DiseasesCardiovascular AbnormalitiesPremature Birth

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
6 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Boston Medical Center

Boston, United StatesOpen Boston Medical Center in Google Maps
SuspendedOne Study Center