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Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

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ClinicalTrials.gov Identifier: NCT02041546
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, 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.

Condition or disease Intervention/treatment Phase
Meconium Aspiration Syndrome Drug: Lung lavage with surfactant Drug: Bolus surfactant Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zekai Tahir Burak Maternity Teaching Hospital
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bolus surfactant
Bolus surfactant 100 mg/kg proctant alfa
Drug: Bolus surfactant
Other Name: Poractant alfa

Active Comparator: Lung lavage with surfactant
Lung lavage with surfactant
Drug: Lung lavage with surfactant
Other Name: Poractant alfa




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041546


Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital

Responsible Party: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02041546     History of Changes
Other Study ID Numbers: ZTB0607
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital:
Lung lavage,
Surfactant,
Duration of mechanical
ventilation

Additional relevant MeSH terms:
Meconium Aspiration Syndrome
Syndrome
Disease
Pathologic Processes
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents