Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Phase 4

Completed

• Conditions: Meconium Aspiration Syndrome
• Interventions: Drug: Bolus surfactant; Drug: Lung lavage with surfactant

• Registration Number: NCT02041546
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus surfactant	Bolus surfactant	Bolus surfactant 100 mg/kg proctant alfa
Lung lavage with surfactant	Lung lavage with surfactant	Lung lavage with surfactant

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	up to 2 weeks	Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Complications	up to 4 weeks	Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.
Duration of Hospital Stay	Up to 8 weeks or till discharge	We will record length of stay in a level III neonatal intensive care unit.
Mortality	Up to 3 months or till discharge	We will record who died until discharge.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital; 🇹🇷 Ankara, Turkey