Early use of surfacen in the respiratory distress syndrome of the newborn. Phase IV

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000099
• Date of registration: 18/04/2011
• Primary sponsor: National Center for Animal Plant and Health (CENSA)
• Public title: Early use of surfacen in the respiratory distress syndrome of the newborn. Phase IV
• Scientific title: Evaluation of effectiveness and safety of SURFACEN early use for the Newborn Respiratory Distress Syndrome. Phase IV
• Date of first enrolment: 01/06/2010
• Target sample size: No applicable. Inclusion for 2 years
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000099-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Yinet Barrese Pérez
• Affiliation: National Coordinating Center for Clinical Trials (CENCEC)

• Name: Dr. Andrés Morilla Guzmán
• Affiliation: Hospital Ángel Arturo Aballí

Key inclusion & exclusion criteria

Inclusion criteria: 1. Newborn of less than 2 hours 2. Gestational age between 26-36 weeks, both inclusive 3. Patients who meet the criteria of early use of SURFACEN 4. Patient's mother (and/or Patient's father) who expressed voluntarily the participation in the study with the signature of the Informed Consent
Exclusion criteria: 1. Major congenital malformations 2. Severe infections 3. Bronchoaspiration of the meconial amniotic liquid 4. Intrapartum asphyxia 5. Pneumothorax or pneumomediastinum before the beginning of the treatment with SURFACEN. 6. Pulmonary hemorrhage before the beginning of the treatment with SURFACEN

Age minimum: no
Age maximum: 2 hours old
Gender: Both

Health Condition(s) or Problem(s) studied

Newborn Respiratory Distress Syndrome

Intervention(s)

Surfacen: A dose of 100 mg/kg by endotracheal instillation. The administration will ocurr in the first two hours of life, after the patient is stable hemodynamically and metabolically. If required, may be administered other 3 doses within 72 hours.

Primary Outcome(s)

Total time of ventilation: time reported in hours/days, between begin and the end of the ventilation. Measuring time: 28 days.

Secondary Outcome(s)

Value of PaO2/FiO2. Measuring time: 1 hour and 4 hours after the first dose of SURFACEN Need for prolonged ventilation (Yes / No). Measuring time: 7 days. Complication Type of Ventilation: complication (s) that occurs in the patient (bronchopulmonary dysplasia, air lock, retinopathy of prematurity, respiratory failure, etc) will be collected (n) (s). Measuring time: 28 days.

Secondary ID(s)

SU07/08

Source(s) of Monetary Support

National Center for Animal Plant and Health (CENSA) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not apply