Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Zekai Tahir Burak Maternity Teaching Hospital

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 Overview

• Status: Completed
• Conditions: Meconium Aspiration Syndrome
• Intervention / Treatment: Drug: Bolus surfactant; Drug: Lung lavage with surfactant

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Zekai Tahir Burak Maternity Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bolus surfactant; Bolus surfactant 100 mg/kg proctant alfa	Drug: Bolus surfactant; Other Names: Poractant alfa
ACTIVE_COMPARATOR: Lung lavage with surfactant	Drug: Lung lavage with surfactant; Other Names: Poractant alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.	up to 4 weeks
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
Mortality	We will record who died until discharge.	Up to 3 months or till discharge

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

General Publications

• Arayici S, Sari FN, Kadioglu Simsek G, Yarci E, Alyamac Dizdar E, Uras N, Canpolat FE, Oguz SS. Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome. J Trop Pediatr. 2019 Oct 1;65(5):491-497. doi: 10.1093/tropej/fmy081.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (ESTIMATE): January 22, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: ventilation; Lung lavage,; Surfactant,; Duration of mechanical
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Fetal Diseases; Pregnancy Complications; Lung Injury; Syndrome; Meconium Aspiration Syndrome; Respiratory System Agents; Pulmonary Surfactants; Poractant alfa
• Other Study ID Numbers: ZTB0607