Trial record 7 of 13 for:    "Meconium aspiration syndrome"

Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT02041546
First received: January 15, 2014
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Meconium Aspiration Syndrome
Drug: Lung lavage with surfactant
Drug: Bolus surfactant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zekai Tahir Burak Maternity Teaching Hospital

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: up to 2 weeks ] [ Designated as safety issue: Yes ]
    Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.


Secondary Outcome Measures:
  • Complications [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.

  • Duration of Hospital Stay [ Time Frame: Up to 8 weeks or till discharge ] [ Designated as safety issue: No ]
    We will record length of stay in a level III neonatal intensive care unit.

  • Mortality [ Time Frame: Up to 3 months or till discharge ] [ Designated as safety issue: No ]
    We will record who died until discharge.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bolus surfactant 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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041546

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey, 06230
Contact: Sema Arayici, MD    903123065271    semadr@hotmail.com   
Principal Investigator: Ugur Dilmen, Prof         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

Responsible Party: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT02041546     History of Changes
Other Study ID Numbers: ZTB0607
Study First Received: January 15, 2014
Last Updated: January 17, 2014
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Meconium Aspiration Syndrome
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014