Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Phase 4CompletedNCT02041546

Zekai Tahir Burak Women's Health Research and Education Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meconium Aspiration Syndrome

Interventions

Lung lavage with surfactantDRUG

Bolus surfactantDRUG

Eligibility

Sex: ALLMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Duration of mechanical ventilation

Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

Time frame: up to 2 weeks

Secondary Outcomes

Complications

Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.

Time frame: up to 4 weeks

Duration of Hospital Stay

We will record length of stay in a level III neonatal intensive care unit.

Time frame: Up to 8 weeks or till discharge

Mortality

We will record who died until discharge.

Time frame: Up to 3 months or till discharge

Data from ClinicalTrials.gov

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