Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 4

Conditions: Meconium Aspiration Syndrome

Treatments: Drug: Lung lavage with surfactant; Drug: Bolus surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT02041546

ZTB0607

Details and patient eligibility

About

Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.

Enrollment: 30 patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.

Exclusion criteria

• Congenital cardiac anomalies
• Major congenital anomalies
• Hemodynamically unstable infants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Bolus surfactant

Active Comparator group

Description:

Bolus surfactant 100 mg/kg proctant alfa

Treatment:

Drug: Bolus surfactant

Lung lavage with surfactant

Active Comparator group

Description:

Lung lavage with surfactant

Treatment:

Drug: Lung lavage with surfactant