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Completed

NCT Number: NCT02041546

Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

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.

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Key information

Conditions

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

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung lavage with surfactant

Drug

Other names: Poractant alfa

Bolus surfactant

Drug

Other names: Poractant alfa

Primary outcomes

  1. Duration of mechanical ventilation

    Time frame: up to 2 weeks

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

Secondary outcomes

  1. Complications

    Time frame: up to 4 weeks

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

  2. Duration of Hospital Stay

    Time frame: Up to 8 weeks or till discharge

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

  3. Mortality

    Time frame: Up to 3 months or till discharge

    We will record who died until discharge.

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Zekai Tahir Burak Maternity Teaching Hospital

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2014
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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