Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Meconium Aspiration Syndrome Clinical Trial

Official title:

Zekai Tahir Burak Maternity Teaching Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041546
• Other study ID #: ZTB0607
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2014
• Last updated: August 2, 2016
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Syndrome

Intervention

Drug:
• Lung lavage with surfactant

• Bolus surfactant

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.	up to 2 weeks	Yes
Secondary	Complications	Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.	up to 4 weeks	Yes
Secondary	Duration of Hospital Stay	We will record length of stay in a level III neonatal intensive care unit.	Up to 8 weeks or till discharge	No
Secondary	Mortality	We will record who died until discharge.	Up to 3 months or till discharge	No