Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

NCT02041546 | Completed Phase 4

• 1 other identifier: ZTB0607
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Aspiration Syndrome

Keywords

Lung lavage,; Surfactant,; Duration of mechanical; ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complications

  up to 4 weeks

• Duration of Hospital Stay

  Up to 8 weeks or till discharge

• Mortality

  Up to 3 months or till discharge

Study Arms (2)

Bolus surfactant

ACTIVE COMPARATOR

Bolus surfactant 100 mg/kg proctant alfa

Drug: Bolus surfactant

Lung lavage with surfactant

ACTIVE COMPARATOR

Lung lavage with surfactant

Drug: Lung lavage with surfactant

Interventions

Lung lavage with surfactant DRUG

Also known as: Poractant alfa

Lung lavage with surfactant

Bolus surfactant DRUG

Also known as: Poractant alfa

Bolus surfactant

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30690595 DERIVED

MeSH Terms

Conditions

Meconium Aspiration Syndrome; Respiratory Aspiration

Interventions

Bronchoalveolar Lavage; Surface-Active Agents; poractant alfa

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

TU (1)